Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Advanced Hepatocellular Carcinoma (MK-3475-224/KEYNOTE-224) (NCT NCT02702414)
NCT ID: NCT02702414
Last Updated: 2024-09-04
Results Overview
ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target and non-target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
Results posted on
2024-09-04
Participant Flow
This study had 2 cohorts with each cohort starting treatment at a different time period during the study. One participant allocated to Cohort 1 withdrew from the study before receiving treatment. This participant was not eligible for safety or efficacy analysis.
Per protocol, final analyses of all outcome measures were planned to be performed during the first course of therapy and collection of adverse events and all-cause mortality were planned to be done in both first and second courses.
Participant milestones
| Measure |
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib
Participants with previously systemically treated HCC received a pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
51
|
|
Overall Study
Treated
|
104
|
51
|
|
Overall Study
Received Second Course of Pembrolizumab
|
4
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
105
|
51
|
Reasons for withdrawal
| Measure |
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib
Participants with previously systemically treated HCC received a pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Overall Study
Death
|
96
|
42
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
8
|
7
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Advanced Hepatocellular Carcinoma (MK-3475-224/KEYNOTE-224)
Baseline characteristics by cohort
| Measure |
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
n=105 Participants
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
n=51 Participants
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.4 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
67.7 Years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
67.6 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2Population: All participants who received at least one dose of study treatment during the first course of therapy.
ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target and non-target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented.
Outcome measures
| Measure |
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
n=104 Participants
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
n=51 Participants
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
18.3 Percentage of participants
Interval 11.4 to 27.1
|
15.7 Percentage of participants
Interval 7.0 to 28.6
|
SECONDARY outcome
Timeframe: Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2Population: All participants who received at least one dose of study treatment and who had a confirmed CR or confirmed PR during the first course of therapy.
DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target and non-target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target and non-target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed, started a new anti-cancer therapy, been lost to follow-up, or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, OR unequivocal progression for non-target lesions, OR appearance of one or more new lesions. The DOR per RECIST 1.1 for all participants who had a confirmed CR or PR is presented.
Outcome measures
| Measure |
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
n=19 Participants
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
n=8 Participants
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Duration of Response (DOR)
|
21.0 Months
Interval 10.7 to
NA=upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
|
16.2 Months
Interval 3.1 to
NA=upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
|
SECONDARY outcome
Timeframe: Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2Population: All participants who received at least one dose of study treatment during the first course of therapy.
DCR was defined as the percentage of participants who had a CR (disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of diameters of target and non-target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD was at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, OR unequivocal progression for non-target lesions, OR appearance of one or more new lesions.\]). CR, PR, and SD were evaluated per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. Participants with missing data were considered as participants whose disease was not under control. The percentage of participants who experienced a confirmed CR, PR, or SD is reported.
Outcome measures
| Measure |
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
n=104 Participants
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
n=51 Participants
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
61.5 Percentage of participants
Interval 51.5 to 70.9
|
56.9 Percentage of participants
Interval 42.2 to 70.7
|
SECONDARY outcome
Timeframe: Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2Population: All participants who received at least one dose of study treatment during the first course of therapy.
TTP was defined as the time from the first dose to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. PD was at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, OR unequivocal progression for non-target lesions, OR appearance of one or more new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. The TTP was analyzed using the product-limit (Kaplan-Meier) method for censored data. TTP per RECIST 1.1 is presented.
Outcome measures
| Measure |
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
n=104 Participants
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
n=51 Participants
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Time to Progression (TTP)
|
4.8 Months
Interval 3.9 to 7.0
|
4.4 Months
Interval 2.5 to 8.6
|
SECONDARY outcome
Timeframe: Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2Population: All participants who received at least one dose of study treatment during the first course of therapy.
PFS was defined as the time from the first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. PD was at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, OR unequivocal progression for non-target lesions, OR appearance of one or more new lesions. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. PFS is presented.
Outcome measures
| Measure |
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
n=104 Participants
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
n=51 Participants
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
4.9 Months
Interval 3.5 to 6.7
|
4.3 Months
Interval 2.1 to 7.8
|
SECONDARY outcome
Timeframe: Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2Population: All participants who received at least one dose of study treatment during the first course of therapy.
OS was determined for all participants and was defined as the time from the first dose to death due to any cause. Participants were censored at the last known alive date. The OS was analyzed using the product-limit (Kaplan-Meier) method for censored data. The OS is presented.
Outcome measures
| Measure |
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
n=104 Participants
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
n=51 Participants
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Overall Survival (OS)
|
13.2 Months
Interval 9.7 to 15.3
|
16.9 Months
Interval 8.3 to 23.1
|
SECONDARY outcome
Timeframe: Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2Population: All participants who received at least one dose of study treatment during the first course of therapy.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experienced at least one AE is presented. Per protocol, final analysis for this outcome measure was planned to be performed during the first course of therapy only.
Outcome measures
| Measure |
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
n=104 Participants
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
n=51 Participants
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Number of Participants Who Experienced At Least One Adverse Event (AE)
|
101 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2Population: All participants who received at least one dose of study treatment during the first course of therapy.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who discontinued study treatment due to an AE is presented. Per protocol, final analysis for this outcome measure was planned to be performed during the first course of therapy only.
Outcome measures
| Measure |
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
n=104 Participants
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve
n=51 Participants
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
|
23 Participants
|
8 Participants
|
Adverse Events
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-First Course
Serious events: 44 serious events
Other events: 96 other events
Deaths: 94 deaths
Cohort 2: HCC-Systemic Therapy Naïve-First Course
Serious events: 21 serious events
Other events: 46 other events
Deaths: 42 deaths
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-Second Course
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Cohort 2: HCC-Systemic Therapy Naïve-Second Course
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-First Course
n=104 participants at risk
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve-First Course
n=51 participants at risk
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-Second Course
n=4 participants at risk
Participants from Cohort 1 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.
|
Cohort 2: HCC-Systemic Therapy Naïve-Second Course
n=1 participants at risk
Participants from Cohort 2 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Viral infection
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
3/104 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Cardiac disorders
Cardiac failure
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Cardiac disorders
Cardiogenic shock
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Eye disorders
Retinal vein occlusion
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Ascites
|
3.8%
4/104 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Constipation
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Melaena
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.9%
3/104 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Asthenia
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Chest pain
|
0.96%
1/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Death
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Fatigue
|
0.96%
1/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
General physical health deterioration
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Pyrexia
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Ulcer haemorrhage
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Hepatobiliary disorders
Jaundice
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Bacteraemia
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Cellulitis
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Device related infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Gastroenteritis viral
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Large intestine infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Pneumonia bacterial
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Sepsis
|
2.9%
3/104 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Septic shock
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
4/104 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Blood bilirubin increased
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Blood creatinine increased
|
0.96%
1/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
3.9%
2/51 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.96%
1/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Nervous system disorders
Ischaemic stroke
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Nervous system disorders
Presyncope
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Nervous system disorders
Syncope
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Renal and urinary disorders
Renal failure
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Vascular disorders
Hypovolaemic shock
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
Other adverse events
| Measure |
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-First Course
n=104 participants at risk
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 2: HCC-Systemic Therapy Naïve-First Course
n=51 participants at risk
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
|
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-Second Course
n=4 participants at risk
Participants from Cohort 1 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.
|
Cohort 2: HCC-Systemic Therapy Naïve-Second Course
n=1 participants at risk
Participants from Cohort 2 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.6%
11/104 • Number of events 12 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
50.0%
2/4 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
8/104 • Number of events 9 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
11.8%
6/51 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
16/104 • Number of events 18 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
15.7%
8/51 • Number of events 9 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.6%
10/104 • Number of events 13 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
3.9%
2/51 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Ascites
|
11.5%
12/104 • Number of events 12 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
11.8%
6/51 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Constipation
|
17.3%
18/104 • Number of events 18 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
7.8%
4/51 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.3%
17/104 • Number of events 21 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.5%
13/51 • Number of events 15 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
5/104 • Number of events 5 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
7.8%
4/51 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
3/104 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Nausea
|
20.2%
21/104 • Number of events 21 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
7.8%
4/51 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
9/104 • Number of events 15 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Asthenia
|
15.4%
16/104 • Number of events 19 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
13.7%
7/51 • Number of events 8 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Fatigue
|
28.8%
30/104 • Number of events 40 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
41.2%
21/51 • Number of events 23 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Mucosal inflammation
|
1.9%
2/104 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Oedema peripheral
|
19.2%
20/104 • Number of events 21 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
27.5%
14/51 • Number of events 15 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
General disorders
Pyrexia
|
4.8%
5/104 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
9.8%
5/51 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Bronchitis
|
3.8%
4/104 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
3/104 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
7.8%
4/51 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Pneumonia
|
2.9%
3/104 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
3.9%
2/51 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Rhinitis
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
3/104 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
13/104 • Number of events 16 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Aspartate aminotransferase increased
|
22.1%
23/104 • Number of events 27 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.8%
6/104 • Number of events 7 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
3.9%
2/51 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Blood bilirubin increased
|
8.7%
9/104 • Number of events 10 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/104 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Investigations
Weight decreased
|
5.8%
6/104 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
16/104 • Number of events 18 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
15.7%
8/51 • Number of events 9 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
3/104 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
5.9%
3/51 • Number of events 3 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.8%
4/104 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.2%
20/104 • Number of events 31 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
9.8%
5/51 • Number of events 8 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
8/104 • Number of events 8 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
3.9%
2/51 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.8%
6/104 • Number of events 8 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
3.9%
2/51 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
8/104 • Number of events 16 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
9.8%
5/51 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
50.0%
2/4 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Nervous system disorders
Dizziness
|
3.8%
4/104 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Nervous system disorders
Headache
|
6.7%
7/104 • Number of events 10 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Psychiatric disorders
Insomnia
|
6.7%
7/104 • Number of events 7 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
7.8%
4/51 • Number of events 4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Renal and urinary disorders
Pollakiuria
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.3%
19/104 • Number of events 21 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
15.7%
8/51 • Number of events 10 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
11/104 • Number of events 15 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
11.8%
6/51 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.96%
1/104 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.8%
6/104 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/51 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
2/104 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
3.9%
2/51 • Number of events 2 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.8%
6/104 • Number of events 6 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
2.0%
1/51 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.1%
24/104 • Number of events 29 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
11.8%
6/51 • Number of events 8 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
25.0%
1/4 • Number of events 1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.5%
14/104 • Number of events 19 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
9.8%
5/51 • Number of events 5 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/4 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
0.00%
0/1 • Up to approximately 87 months
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
|
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 The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER