Trial Outcomes & Findings for A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment (NCT NCT04338269)
NCT ID: NCT04338269
Last Updated: 2025-04-04
Results Overview
Progression Free Survival (PFS) is defined as the time from randomization to disease progression, as determined by the Independent Review Facility (IRF) per RECIST v1.1, or death from any cause, whichever occurs first. Data for patients who have not experienced disease progression or death were censored at the last tumor assessment date. Data for patients with no postbaseline tumor assessments were censored at the randomization date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
522 participants
Primary outcome timeframe
From randomization to the first occurrence of disease progression according to RECIST v1.1 (up to 2 years 5 months).
Results posted on
2025-04-04
Participant Flow
The study was conducted at 147 locations in 15 countries: Argentina, Australia, Canada, Denmark, France, Germany, Greece, Italy, Japan, Republic of Korea, Poland, Russian Federation, Spain, United Kingdom, United States of America.
Participant milestones
| Measure |
Cabozantinib (Control)
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
259
|
263
|
|
Overall Study
Received at Least One Dose of Study Treatment
|
256
|
262
|
|
Overall Study
COMPLETED
|
157
|
161
|
|
Overall Study
NOT COMPLETED
|
102
|
102
|
Reasons for withdrawal
| Measure |
Cabozantinib (Control)
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Overall Study
Death
|
86
|
89
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
14
|
11
|
Baseline Characteristics
A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
Baseline characteristics by cohort
| Measure |
Cabozantinib (Control)
n=259 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=263 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Total
n=522 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
144 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
115 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Age, Customized
|
61.8 Number
STANDARD_DEVIATION 10.2 • n=5 Participants
|
61.8 Number
STANDARD_DEVIATION 9.9 • n=7 Participants
|
61.8 Number
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
212 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
444 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
213 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the first occurrence of disease progression according to RECIST v1.1 (up to 2 years 5 months).Population: The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.
Progression Free Survival (PFS) is defined as the time from randomization to disease progression, as determined by the Independent Review Facility (IRF) per RECIST v1.1, or death from any cause, whichever occurs first. Data for patients who have not experienced disease progression or death were censored at the last tumor assessment date. Data for patients with no postbaseline tumor assessments were censored at the randomization date.
Outcome measures
| Measure |
Cabozantinib (Control)
n=259 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=263 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1
|
10.81 Months
Interval 9.95 to 12.45
|
10.55 Months
Interval 9.76 to 12.25
|
PRIMARY outcome
Timeframe: From randomization to death due to any cause (up to 2 years 5 months).Population: The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.
From randomization to death due to any cause. Data for patients who are not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Patients who do not have post-baseline information were censored at the date of randomization.
Outcome measures
| Measure |
Cabozantinib (Control)
n=259 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=263 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 21.13 to
Not estimable due to too few events having occurred.
|
25.72 Months
Interval 21.52 to
The upper limit of the 95% CI was not estimable because too few events had occurred.
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).Population: The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.
Progression Free Survival (PFS) is defined as the time from randomization to disease progression, as determined by the Investigators per RECIST v1.1, or death from any cause, whichever occurs first. Data for patients who have not experienced disease progression or death were censored at the last tumor assessment date. Data for patients with no postbaseline tumor assessments were censored at the randomization date.
Outcome measures
| Measure |
Cabozantinib (Control)
n=259 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=263 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Progression Free Survival (PFS) as Assessed by Investigators (INV-PFS), According to RECIST v1.1
|
10.41 Months
Interval 8.51 to 12.29
|
10.38 Months
Interval 8.41 to 10.94
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).Population: The ORR evaluable population is defined as participants with measurable disease at baseline. There were discrepancies between the IRF and INV assessments of participants' measurable diseases at baseline, which are reflected in the number of participants analyzed.
Overall Response Rate (ORR) is defined as the proportion of participants who had an objective response (complete response \[CR\] or partial response \[PR\]) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1. in the ORR evaluable population, defined as patients with measurable disease at baseline.
Outcome measures
| Measure |
Cabozantinib (Control)
n=259 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=263 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1
Responders (CR + PR)
|
41.7 Percentage of Participants
Interval 35.63 to 47.96
|
38.0 Percentage of Participants
Interval 32.13 to 44.19
|
|
Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1
Complete Response (CR)
|
0.8 Percentage of Participants
Interval 0.09 to 2.76
|
1.5 Percentage of Participants
Interval 0.42 to 3.85
|
|
Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1
Partial Response (PR)
|
40.9 Percentage of Participants
Interval 34.88 to 47.18
|
36.5 Percentage of Participants
Interval 30.67 to 42.64
|
|
Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1
Stable Disease (SD)
|
46.3 Percentage of Participants
Interval 40.14 to 52.61
|
48.3 Percentage of Participants
Interval 42.11 to 54.51
|
|
Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1
Progressive Disease (PD)
|
6.6 Percentage of Participants
Interval 3.87 to 10.3
|
9.1 Percentage of Participants
Interval 5.93 to 13.27
|
|
Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1
Not Evaluable
|
0 Percentage of Participants
Interval 0.0 to 1.4
|
0.8 Percentage of Participants
Interval 0.1 to 2.7
|
|
Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1
Missing
|
5.4 Percentage of Participants
Interval 3.0 to 8.9
|
3.8 Percentage of Participants
Interval 1.8 to 6.9
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).Population: The ORR evaluable population is defined as participants with measurable disease at baseline. There were discrepancies between the IRF and INV assessments of participants' measurable diseases at baseline, which are reflected in the number of participants analyzed.
Overall Response Rate (ORR) is defined as the proportion of participants who had an objective response (complete response \[CR\] or partial response \[PR\]) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1. in the ORR evaluable population, defined as patients with measurable disease at baseline.
Outcome measures
| Measure |
Cabozantinib (Control)
n=254 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=259 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1
Partial Response (PR)
|
40.2 Percentage of Participants
Interval 34.08 to 46.47
|
40.5 Percentage of Participants
Interval 34.51 to 46.79
|
|
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1
Responders (CR + PR)
|
40.9 Percentage of Participants
Interval 34.84 to 47.27
|
40.5 Percentage of Participants
Interval 34.51 to 46.79
|
|
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1
Complete Response (CR)
|
0.8 Percentage of Participants
Interval 0.1 to 2.82
|
0 Percentage of Participants
Interval 0.0 to 1.41
|
|
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1
Stable Disease (SD)
|
47.6 Percentage of Participants
Interval 41.36 to 53.97
|
50.6 Percentage of Participants
Interval 44.32 to 56.82
|
|
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1
Progressive Disease (PD)
|
5.1 Percentage of Participants
Interval 2.75 to 8.59
|
4.2 Percentage of Participants
Interval 2.14 to 7.47
|
|
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1
Not Evaluable
|
0.8 Percentage of Participants
Interval 0.1 to 2.8
|
0.8 Percentage of Participants
Interval 0.1 to 2.8
|
|
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1
Missing
|
5.5 Percentage of Participants
Interval 3.0 to 9.1
|
3.9 Percentage of Participants
Interval 1.9 to 7.0
|
SECONDARY outcome
Timeframe: From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)Population: The DOR evaluable population is defined as participants with measurable disease at baseline who experienced a a confirmed objective response (complete response \[CR\] or partial response \[PR\]).
Duration of Response (DOR) is defined as the time from the first occurrence of a confirmed objective response (complete response \[CR\] or partial response \[PR\]) to disease progression, or death, whichever occurs first. Data for participants who have not experienced disease progression or death will be censored at the last tumor assessment date. If no tumor assessments were performed after the date of the first occurrence of CR or PR, data for DOR will be censored at the date of the first occurrence of CR or PR.
Outcome measures
| Measure |
Cabozantinib (Control)
n=108 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=100 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Investigator-assessed Duration of Response (DOR) (INV-DOR) According to RECIST v1.1
|
12.19 Months
Interval 9.72 to 14.52
|
NA Months
Interval 10.38 to
Not estimable due to too few events having occurred.
|
SECONDARY outcome
Timeframe: From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)Population: The DOR evaluable population is defined as participants with measurable disease at baseline who experienced a a confirmed objective response (complete response \[CR\] or partial response \[PR\]).
Duration of Response (DOR) is defined as the time from the first occurrence of a confirmed objective response (complete response \[CR\] or partial response \[PR\]) to disease progression, or death, whichever occurs first. Data for participants who have not experienced disease progression or death will be censored at the last tumor assessment date. If no tumor assessments were performed after the date of the first occurrence of CR or PR, data for DOR will be censored at the date of the first occurrence of CR or PR.
Outcome measures
| Measure |
Cabozantinib (Control)
n=104 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=105 Participants
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Independent Review Facility (IRF)-Assessed Duration of Response (DOR) (IRF-DOR) According to RECIST v1.1
|
14.75 Months
Interval 11.3 to 20.01
|
12.65 Months
Interval 10.51 to 17.38
|
Adverse Events
Cabozantinib (Control)
Serious events: 84 serious events
Other events: 251 other events
Deaths: 87 deaths
Atezolizumab + Cabozantinib
Serious events: 126 serious events
Other events: 255 other events
Deaths: 89 deaths
Serious adverse events
| Measure |
Cabozantinib (Control)
n=256 participants at risk
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=262 participants at risk
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
3/256 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.9%
5/262 • Number of events 5 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Faecaloma
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.1%
3/262 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.1%
3/262 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Asthenia
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.1%
3/262 • Number of events 4 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Death
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
General physical health deterioration
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Generalised oedema
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Malaise
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Pain
|
1.2%
3/256 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Pyrexia
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
2.7%
7/262 • Number of events 7 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Biliary colic
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Anal abscess
|
0.39%
1/256 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Appendicitis
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Aspergilloma
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
COVID-19
|
2.0%
5/256 • Number of events 5 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.5%
4/262 • Number of events 4 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Chronic sinusitis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Encephalitis
|
0.39%
1/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Febrile infection
|
0.39%
1/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Fournier's gangrene
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Human herpesvirus 6 encephalitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Influenza
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Kidney infection
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Meningitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Otitis externa
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Pneumonia
|
2.0%
5/256 • Number of events 5 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.5%
4/262 • Number of events 4 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Sepsis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.5%
4/262 • Number of events 5 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Spinal cord infection
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.9%
5/262 • Number of events 5 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Vascular device infection
|
0.78%
2/256 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Blood pressure increased
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Platelet count decreased
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.5%
4/262 • Number of events 4 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.5%
4/262 • Number of events 4 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.78%
2/256 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Enchondromatosis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Cerebrovascular stenosis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Radicular pain
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Seizure
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Product Issues
Device malfunction
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.78%
2/256 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.5%
4/262 • Number of events 6 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Urethral obstruction
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.5%
4/262 • Number of events 4 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.78%
2/256 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
6/256 • Number of events 6 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
4.2%
11/262 • Number of events 11 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 3 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/256 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Vascular disorders
Embolism
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.00%
0/262 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Vascular disorders
Hypertension
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.76%
2/262 • Number of events 2 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Vascular disorders
Thrombosis
|
0.39%
1/256 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
0.38%
1/262 • Number of events 1 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
Other adverse events
| Measure |
Cabozantinib (Control)
n=256 participants at risk
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
Atezolizumab + Cabozantinib
n=262 participants at risk
Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.4%
47/256 • Number of events 64 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
19.8%
52/262 • Number of events 64 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.0%
18/256 • Number of events 35 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
5.7%
15/262 • Number of events 30 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.0%
23/256 • Number of events 33 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
8.0%
21/262 • Number of events 28 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
37.9%
97/256 • Number of events 111 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
36.3%
95/262 • Number of events 115 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
33/256 • Number of events 41 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
5.3%
14/262 • Number of events 16 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
17/256 • Number of events 17 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
9.5%
25/262 • Number of events 27 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Constipation
|
16.4%
42/256 • Number of events 46 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
14.1%
37/262 • Number of events 44 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
69.9%
179/256 • Number of events 340 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
64.9%
170/262 • Number of events 313 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
20/256 • Number of events 24 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
9.9%
26/262 • Number of events 31 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Nausea
|
35.9%
92/256 • Number of events 131 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
29.0%
76/262 • Number of events 98 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
16.8%
43/256 • Number of events 48 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
19.1%
50/262 • Number of events 66 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.4%
42/256 • Number of events 77 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
13.7%
36/262 • Number of events 48 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Asthenia
|
29.3%
75/256 • Number of events 88 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
28.6%
75/262 • Number of events 108 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Fatigue
|
23.8%
61/256 • Number of events 83 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
27.1%
71/262 • Number of events 92 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Mucosal inflammation
|
19.9%
51/256 • Number of events 70 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
17.2%
45/262 • Number of events 56 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Oedema peripheral
|
4.7%
12/256 • Number of events 12 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
6.1%
16/262 • Number of events 16 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
General disorders
Pyrexia
|
5.9%
15/256 • Number of events 20 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
12.2%
32/262 • Number of events 36 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
COVID-19
|
12.1%
31/256 • Number of events 32 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
13.7%
36/262 • Number of events 39 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
15/256 • Number of events 19 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
8.8%
23/262 • Number of events 43 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
22.3%
57/256 • Number of events 87 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
23.7%
62/262 • Number of events 93 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
23.8%
61/256 • Number of events 92 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
22.9%
60/262 • Number of events 87 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.5%
14/256 • Number of events 15 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
6.5%
17/262 • Number of events 20 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Blood bilirubin increased
|
5.1%
13/256 • Number of events 24 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
4.2%
11/262 • Number of events 14 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Blood creatinine increased
|
6.2%
16/256 • Number of events 23 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
8.4%
22/262 • Number of events 24 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.3%
11/256 • Number of events 13 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
5.7%
15/262 • Number of events 19 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.5%
14/256 • Number of events 14 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
6.5%
17/262 • Number of events 17 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Investigations
Weight decreased
|
25.0%
64/256 • Number of events 78 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
17.6%
46/262 • Number of events 51 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.9%
97/256 • Number of events 119 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
37.8%
99/262 • Number of events 122 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.9%
15/256 • Number of events 24 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
1.5%
4/262 • Number of events 9 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.6%
17/256 • Number of events 18 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
7.3%
19/262 • Number of events 22 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.0%
18/256 • Number of events 27 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
7.3%
19/262 • Number of events 27 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.3%
29/256 • Number of events 39 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
9.9%
26/262 • Number of events 40 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
18.0%
46/256 • Number of events 62 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
14.1%
37/262 • Number of events 61 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.2%
26/256 • Number of events 35 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
8.4%
22/262 • Number of events 30 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
25/256 • Number of events 31 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
11.1%
29/262 • Number of events 34 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
18/256 • Number of events 19 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
8.8%
23/262 • Number of events 24 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.1%
8/256 • Number of events 9 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
5.3%
14/262 • Number of events 16 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
13/256 • Number of events 14 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
6.9%
18/262 • Number of events 18 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
22/256 • Number of events 24 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
5.3%
14/262 • Number of events 15 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Dizziness
|
3.5%
9/256 • Number of events 10 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
8.8%
23/262 • Number of events 28 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Dysgeusia
|
14.8%
38/256 • Number of events 43 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
14.9%
39/262 • Number of events 40 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Nervous system disorders
Headache
|
10.5%
27/256 • Number of events 31 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
10.3%
27/262 • Number of events 34 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.1%
13/256 • Number of events 13 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
7.3%
19/262 • Number of events 20 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
16.0%
41/256 • Number of events 52 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
15.3%
40/262 • Number of events 57 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.0%
23/256 • Number of events 27 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
11.1%
29/262 • Number of events 35 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.7%
30/256 • Number of events 31 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
14.1%
37/262 • Number of events 42 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.2%
21/256 • Number of events 22 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
8.0%
21/262 • Number of events 23 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.0%
18/256 • Number of events 25 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
3.8%
10/262 • Number of events 11 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.5%
9/256 • Number of events 9 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
6.9%
18/262 • Number of events 22 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.1%
13/256 • Number of events 13 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
3.1%
8/262 • Number of events 9 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.2%
21/256 • Number of events 23 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
4.2%
11/262 • Number of events 13 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
7.4%
19/256 • Number of events 19 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
3.4%
9/262 • Number of events 9 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
41.0%
105/256 • Number of events 130 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
38.5%
101/262 • Number of events 133 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.8%
20/256 • Number of events 21 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
8.0%
21/262 • Number of events 23 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
27/256 • Number of events 32 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
12.6%
33/262 • Number of events 41 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
|
Vascular disorders
Hypertension
|
33.6%
86/256 • Number of events 103 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
26.7%
70/262 • Number of events 78 • All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Collaborators are Exelixis and Chugai. The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER