Trial Outcomes & Findings for Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004) (NCT NCT04740307)
NCT ID: NCT04740307
Last Updated: 2026-06-30
Results Overview
DLTs were defined as follows unless determined to be unrelated to study intervention: any Grade 4 nonhematologic toxicity (not laboratory); any Grade 4 hematologic toxicity lasting \>7 days (Grade 4 lymphopenia lasting ≥21 days); Grade 3 platelet count decreased if associated with clinically significant hemorrhage; any Grade 3 nonhematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care; any clinically significant Grade 3 or Grade 4 nonhematologic laboratory abnormality if: medical intervention is required to treat participant, or abnormality leads to hospitalization, or abnormality persists for \>1 week (or bilirubin if persists \>4 weeks); aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \>10.0 times upper limit of normal (ULN) or \>10.0 times baseline if baseline \>ULN; any febrile neutropenia Grade 3 or Grade 4; a treatment-related adverse event (AE) causing discontinuation of study intervention during the DLT window; any Grade 5 toxicity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
3 weeks
Results posted on
2026-06-30
Participant Flow
116 participants were enrolled. Of the 116 enrolled participants, 6 participants completed a safety lead-in phase. 1 participant was enrolled in the study in error and did not receive study treatment. After discontinuation of pembrolizumab/quavonlimab, 5 participants switched over to treatment with pembrolizumab plus lenvatinib.
Participant milestones
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Overall Study
STARTED
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116
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Overall Study
Treated With Pembrolizumab/Quavonlimab + Lenvatinib
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115
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Overall Study
Switched Over to Pembrolizumab + Lenvatinib
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5
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
|
116
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Reasons for withdrawal
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Overall Study
Death
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89
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Overall Study
Lost to Follow-up
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1
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Overall Study
Randomized By Mistake Without Study Treatment
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1
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Overall Study
Sponsor Decision
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23
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)
Baseline characteristics by cohort
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=116 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Age, Continuous
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63.4 Years
STANDARD_DEVIATION 10.8 • n=20 Participants
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Sex: Female, Male
Female
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21 Participants
n=20 Participants
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Sex: Female, Male
Male
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95 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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110 Participants
n=20 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=20 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Asian
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53 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=20 Participants
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Race (NIH/OMB)
White
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59 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: 3 weeksPopulation: The analysis population consisted of all participants from the safety lead-in phase who received at least one dose of study intervention and who met the criteria for DLT evaluability (ie, finished the DLT-evaluation period without a DLT or experienced a DLT in the DLT-evaluation period). The DLT-evaluation period was 3 weeks.
DLTs were defined as follows unless determined to be unrelated to study intervention: any Grade 4 nonhematologic toxicity (not laboratory); any Grade 4 hematologic toxicity lasting \>7 days (Grade 4 lymphopenia lasting ≥21 days); Grade 3 platelet count decreased if associated with clinically significant hemorrhage; any Grade 3 nonhematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care; any clinically significant Grade 3 or Grade 4 nonhematologic laboratory abnormality if: medical intervention is required to treat participant, or abnormality leads to hospitalization, or abnormality persists for \>1 week (or bilirubin if persists \>4 weeks); aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \>10.0 times upper limit of normal (ULN) or \>10.0 times baseline if baseline \>ULN; any febrile neutropenia Grade 3 or Grade 4; a treatment-related adverse event (AE) causing discontinuation of study intervention during the DLT window; any Grade 5 toxicity.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=6 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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Number of Participants With a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase
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0 Participants
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PRIMARY outcome
Timeframe: Up to approximately 44 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with an AE was reported.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Number of Participants With ≥1 Adverse Event (AE)
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114 Participants
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PRIMARY outcome
Timeframe: Up to approximately 44 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. The number of participants with an SAE was reported.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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Number of Participants With ≥1 Serious Adverse Event (SAE)
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52 Participants
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PRIMARY outcome
Timeframe: Up to approximately 44 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs associated with pembrolizumab/quavonlimab exposure may represent an immune-related response. A list of irAEs was pre-specified for the compound of pembrolizumab/quavonlimab. The number of participants with an irAE was reported.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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Number of Participants With ≥1 Immune-related AE (irAE)
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55 Participants
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PRIMARY outcome
Timeframe: Up to approximately 44 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) included any of the following events if the event is considered not due to disease progression as judged by the investigator: among participants with Baseline ALT \<2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT \>3 × the Baseline level; ALT \>500 U/L regardless of baseline level; total bilirubin \>3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for \>3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE was reported.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Number of Participants With ≥1 Hepatic AE
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17 Participants
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PRIMARY outcome
Timeframe: Up to approximately 40 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Number of Participants Discontinuing Study Treatment Due to an AE
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31 Participants
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PRIMARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study intervention.
ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR. The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
|
38.3 Percentage of Participants
Interval 29.4 to 47.8
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SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study intervention and had a documented confirmed response (complete response \[CR\] or partial response \[PR\]) per RECIST 1.1 as assessed by BICR.
For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=44 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
|
12.4 Months
Interval 6.4 to 14.6
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SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study intervention.
DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR
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79.1 Percentage of Participants
Interval 70.6 to 86.1
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SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least 1 dose of study intervention.
PFS was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
|
8.2 Months
Interval 6.2 to 10.2
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SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least 1 dose of study intervention.
TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. TTP per RECIST 1.1 as assessed by BICR was presented.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Time-To-Progression (TTP) Per RECIST 1.1 as Assessed by BICR
|
8.5 Months
Interval 6.4 to 11.2
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least 1 dose of study intervention.
OS was defined as the time from the first dose of study intervention to death due to any cause.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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Overall Survival (OS)
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21.0 Months
Interval 15.7 to 26.0
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least 1 dose of study intervention.
ORR was defined as the percentage of participants who achieve a confirmed CR (disappearance of any intratumoral arterial enhancement in all target lesions) or a PR (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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ORR Per Modified RECIST (mRECIST) as Assessed by BICR
|
51.3 Percentage of Participants
Interval 41.8 to 60.7
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response.
For participants who demonstrate confirmed CR or PR per mRECIST assessed by BICR, DOR is defined as the time from the first documented evidence of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions) until PD or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=59 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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DOR Per mRECIST as Assessed by BICR
|
10.0 Months
Interval 6.6 to 12.6
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least 1 dose of study intervention.
DCR was defined as the percentage of participants who have achieved CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions), or SD (any cases that do not qualify for either PR or PD) after ≥6 weeks (the start of the window for the first scheduled scan) per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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DCR Per mRECIST as Assessed by BICR
|
81.7 Percentage of Participants
Interval 73.5 to 88.3
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least 1 dose of study intervention.
PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. PFS per mRECIST as assessed by BICR was reported.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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PFS Per mRECIST as Assessed by BICR
|
7.2 Months
Interval 6.2 to 9.2
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: The analysis population consisted of all allocated participants who received at least 1 dose of study intervention.
TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. TTP per mRECIST as assessed by BICR was presented.
Outcome measures
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 Participants
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity. Participants who experienced intolerable toxicity to pembrolizumab/quavonlimab were able to re-initiate treatment with pembrolizumab Q6W for up to 2 years (at the sponsor's discretion) plus lenvatinib.
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|---|---|
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TTP Per mRECIST as Assessed by BICR
|
8.2 Months
Interval 6.2 to 10.4
|
Adverse Events
Pembrolizumab/Quavonlimab + Lenvatinib
Serious events: 52 serious events
Other events: 113 other events
Deaths: 86 deaths
Switched Over to MK-3475 + Lenvatinib
Serious events: 1 serious events
Other events: 5 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 participants at risk
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity.
|
Switched Over to MK-3475 + Lenvatinib
n=5 participants at risk
At the sponsor's discretion, participants from the pembrolizumab/quavonlimab + lenvatinib arm who discontinued pembrolizumab/quavonlimab switched over to treatment with pembrolizumab via IV infusion Q6W for up to 2 years, plus lenvatinib.
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|---|---|---|
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General disorders
Asthenia
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Sinus bradycardia
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Immune-mediated thyroiditis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Colitis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
5.2%
6/115 • Number of events 6 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Subileus
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Death
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Malaise
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Oedema peripheral
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Pyrexia
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Cholangitis
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Appendicitis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Arthritis infective
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Biliary sepsis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Biliary tract infection
|
0.87%
1/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Cytomegalovirus enterocolitis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Fournier's gangrene
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Infection
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Meningitis aseptic
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia aspiration
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Septic shock
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Vascular device infection
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood bilirubin increased
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Liver function test increased
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
SARS-CoV-2 test positive
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Weight decreased
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Encephalopathy
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Opsoclonus myoclonus
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Somnolence
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Product Issues
Device occlusion
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Sarcoid-like reaction
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Haematoma
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
Other adverse events
| Measure |
Pembrolizumab/Quavonlimab + Lenvatinib
n=115 participants at risk
Participants received pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years or until progressive disease or unacceptable toxicity, plus lenvatinib orally for up to 5 years or until progressive disease or unacceptable toxicity.
|
Switched Over to MK-3475 + Lenvatinib
n=5 participants at risk
At the sponsor's discretion, participants from the pembrolizumab/quavonlimab + lenvatinib arm who discontinued pembrolizumab/quavonlimab switched over to treatment with pembrolizumab via IV infusion Q6W for up to 2 years, plus lenvatinib.
|
|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
15.7%
18/115 • Number of events 19 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Hypothyroidism
|
21.7%
25/115 • Number of events 36 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.3%
13/115 • Number of events 15 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
40.0%
2/5 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.1%
7/115 • Number of events 10 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 3 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Sinus tachycardia
|
3.5%
4/115 • Number of events 4 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
7/115 • Number of events 8 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.7%
18/115 • Number of events 24 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.4%
12/115 • Number of events 14 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Constipation
|
18.3%
21/115 • Number of events 23 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
39.1%
45/115 • Number of events 90 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
60.0%
3/5 • Number of events 3 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dry mouth
|
5.2%
6/115 • Number of events 6 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
7/115 • Number of events 8 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Nausea
|
13.9%
16/115 • Number of events 19 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.6%
3/115 • Number of events 3 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
6.1%
7/115 • Number of events 9 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Toothache
|
5.2%
6/115 • Number of events 6 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
11/115 • Number of events 19 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Asthenia
|
23.5%
27/115 • Number of events 42 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Fatigue
|
25.2%
29/115 • Number of events 33 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Oedema peripheral
|
13.0%
15/115 • Number of events 19 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
40.0%
2/5 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Pyrexia
|
15.7%
18/115 • Number of events 28 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Bronchitis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19
|
8.7%
10/115 • Number of events 10 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Paronychia
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Periodontitis
|
0.87%
1/115 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
6/115 • Number of events 7 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
5/115 • Number of events 5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
21.7%
25/115 • Number of events 36 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Amylase increased
|
13.0%
15/115 • Number of events 22 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
27.0%
31/115 • Number of events 43 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.0%
8/115 • Number of events 8 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood bilirubin increased
|
17.4%
20/115 • Number of events 36 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood creatinine increased
|
5.2%
6/115 • Number of events 6 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
7.0%
8/115 • Number of events 11 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Electrocardiogram QT prolonged
|
1.7%
2/115 • Number of events 3 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.4%
12/115 • Number of events 17 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Lipase increased
|
16.5%
19/115 • Number of events 25 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Neutrophil count decreased
|
9.6%
11/115 • Number of events 17 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Platelet count decreased
|
15.7%
18/115 • Number of events 31 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
SARS-CoV-2 test positive
|
4.3%
5/115 • Number of events 6 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Weight decreased
|
19.1%
22/115 • Number of events 26 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
40.0%
2/5 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
White blood cell count decreased
|
7.0%
8/115 • Number of events 11 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.3%
36/115 • Number of events 48 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.1%
7/115 • Number of events 9 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.0%
8/115 • Number of events 9 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.8%
9/115 • Number of events 12 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.5%
4/115 • Number of events 4 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 3 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.4%
12/115 • Number of events 16 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.9%
24/115 • Number of events 31 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
15/115 • Number of events 19 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.2%
6/115 • Number of events 6 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.7%
18/115 • Number of events 25 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
6/115 • Number of events 9 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Dizziness
|
5.2%
6/115 • Number of events 7 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Headache
|
14.8%
17/115 • Number of events 19 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Psychiatric disorders
Confusional state
|
1.7%
2/115 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Psychiatric disorders
Insomnia
|
6.1%
7/115 • Number of events 7 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
3/115 • Number of events 3 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Proteinuria
|
23.5%
27/115 • Number of events 44 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Reproductive system and breast disorders
Penile blister
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
10/115 • Number of events 11 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
13.0%
15/115 • Number of events 18 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.0%
8/115 • Number of events 9 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.8%
9/115 • Number of events 11 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/115 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 2 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
20.9%
24/115 • Number of events 30 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.9%
24/115 • Number of events 26 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
20/115 • Number of events 28 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypertension
|
37.4%
43/115 • Number of events 61 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
40.0%
2/5 • Number of events 4 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypotension
|
3.5%
4/115 • Number of events 5 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.0%
1/5 • Number of events 1 • Up to approximately 51 months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER