Trial Outcomes & Findings for Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055) (NCT NCT02255097)
NCT ID: NCT02255097
Last Updated: 2022-06-28
Results Overview
ORR was assessed by RECIST 1.1 by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. Participants with missing data were considered non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2022-06-28
Participant Flow
Participants were eligible to receive second course treatment with pembrolizumab if they met criteria for re-treatment. Per protocol, response or progression during the second course of pembrolizumab was not counted towards efficacy outcome measures and adverse events during the second course of pembrolizumab were not counted towards safety outcome measures.
Final analyses for all primary outcome measures were done at the protocol-specified primary outcome measure met date. The analyses for all secondary outcome measures and the collection of adverse events were updated at the end of study date. One participant allocated to receive pembrolizumab did not receive treatment. This participant was not eligible for safety or efficacy analysis.
Participant milestones
| Measure |
Pembrolizumab
Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Overall Study
STARTED
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172
|
|
Overall Study
Treated
|
171
|
|
Overall Study
Received Second Course of Pembrolizumab
|
3
|
|
Overall Study
COMPLETED
|
0
|
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Overall Study
NOT COMPLETED
|
172
|
Reasons for withdrawal
| Measure |
Pembrolizumab
Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Overall Study
Death
|
151
|
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Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Participation in Study Discontinued by Sponsor
|
8
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Allocated but not treated
|
1
|
Baseline Characteristics
Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055)
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=172 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status
≥50%
|
44 Participants
n=99 Participants
|
|
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status
≥1 - <50%
|
77 Participants
n=99 Participants
|
|
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status
<1%
|
46 Participants
n=99 Participants
|
|
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status
Unknown
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: All participants who received at least one dose of study treatment
ORR was assessed by RECIST 1.1 by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Pembrolizumab
n=171 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
|
16.4 Percentage of participants
Interval 11.2 to 22.8
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: All participants who received at least one dose of study treatment with a tumor proportion score ≥50%
Participants with a strong PD-L1 expression status were evaluated for ORR by RECIST 1.1. The expression of PD-L1 was determined by immunohistochemistry (IHC) and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50%. ORR was assessed by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Pembrolizumab
n=44 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
27.3 Percentage of participants
Interval 15.0 to 42.8
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PRIMARY outcome
Timeframe: Up to 27 monthsPopulation: All participants who received at least one dose of study treatment
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product, whether or not considered related to the product. Worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, or was another important medical event. Per protocol, analysis for this outcome measure was planned to be performed during the initial (first) course of therapy only.
Outcome measures
| Measure |
Pembrolizumab
n=171 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Number of Participants Experiencing an Adverse Event (AE)
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166 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: All participants who received at least one dose of study treatment
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product, whether or not considered related to the product. Worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, or was another important medical event. Per protocol, analysis for this outcome measure was planned to be performed during the initial (first) course of therapy only.
Outcome measures
| Measure |
Pembrolizumab
n=171 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Number of Participants Discontinuing Study Drug Due to an AE
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24 Participants
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SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a tumor proportion score ≥1%
Participants with a positive PD-L1 expression status were evaluated for ORR by RECIST 1.1. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1%. ORR was assessed by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Pembrolizumab
n=121 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
18.2 Percentage of participants
Interval 11.8 to 26.2
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a HPV-positive tumor
Participants with a HPV-positive tumor biopsy were evaluated for ORR by RECIST 1.1. ORR was assessed by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Pembrolizumab
n=71 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Human Papillomavirus (HPV) Positive Tumors
|
14.1 Percentage of participants
Interval 7.0 to 24.4
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment
ORR was assessed by modified RECIST 1.1 by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Pembrolizumab
n=171 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Objective Response Rate (ORR) by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
|
16.4 Percentage of participants
Interval 11.2 to 22.8
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a tumor proportion score ≥1%
Participants with a positive PD-L1 expression status were evaluated for ORR by modified RECIST 1.1. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a tumor proportion score ≥1%. ORR was assessed by performing imaging every 6-9 weeks after the first dose of treatment. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Pembrolizumab
n=121 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Objective Response Rate (ORR) by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
18.2 Percentage of participants
Interval 11.8 to 26.2
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a tumor proportion score ≥50%
Participants with a strong positive PD-L1 expression status were evaluated for ORR by modified RECIST 1.1. PD-L1 expression was determined by IHC and strong PD-L1 positive was defined as a tumor proportion score ≥50%. ORR was defined as the percentage of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Pembrolizumab
n=44 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Objective Response Rate (ORR) by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
27.3 Percentage of participants
Interval 15.0 to 42.8
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a best overall response as confirmed complete response or partial response
DOR was based on RECIST 1.1 and measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.
Outcome measures
| Measure |
Pembrolizumab
n=28 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Response Duration (DOR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
|
15.7 Months
Interval 2.8 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 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a combined positive score ≥1% and a best overall response as confirmed complete response or partial response
Participants with a positive PD-L1 expression status were evaluated for DOR based on RECIST 1.1. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a PD-L1 combined positive score ≥1%. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.
Outcome measures
| Measure |
Pembrolizumab
n=25 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Response Duration (DOR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
15.7 Months
Interval 2.8 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 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a tumor proportion score ≥50% and a best overall response as confirmed complete response or partial response
Participants with a strong PD-L1 expression status were evaluated for DOR based n RECIST 1.1. PD-L1 expression was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50%. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.
Outcome measures
| Measure |
Pembrolizumab
n=12 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Response Duration (DOR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
22.8 Months
Interval 4.2 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 76.9 monthsPopulation: All participants who received at least one dose of study treatment
PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Outcome measures
| Measure |
Pembrolizumab
n=171 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
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Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
|
2.1 Months
Interval 2.1 to 2.1
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a combined positive score ≥1%
Participants with a positive PD-L1 expression status were evaluated for PFS. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a PD-L1 combined positive score ≥1%. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Outcome measures
| Measure |
Pembrolizumab
n=141 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
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|---|---|
|
Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
2.1 Months
Interval 2.0 to 2.1
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a tumor proportion score ≥50%
Participants with a strong PD-L1 expression status were evaluated for PFS by modified RECIST 1.1. PD-L1 expression was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50%. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Outcome measures
| Measure |
Pembrolizumab
n=44 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
|
|---|---|
|
Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
2.1 Months
Interval 1.8 to 3.6
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment
OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Outcome measures
| Measure |
Pembrolizumab
n=171 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
|
|---|---|
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Overall Survival (OS) in All Participants
|
8.5 Months
Interval 6.6 to 11.1
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a combined positive score ≥1%
Participants with a positive PD-L1 expression status were evaluated for OS. PD-L1 expression was determined by IHC and PD-L1 positive was defined as a PD-L1 combined positive score ≥1%. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Outcome measures
| Measure |
Pembrolizumab
n=141 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
|
|---|---|
|
Overall Survival (OS) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
9.0 Months
Interval 6.2 to 11.8
|
SECONDARY outcome
Timeframe: Up to 76.9 monthsPopulation: All participants who received at least one dose of study treatment with a tumor proportion score ≥50%
Participants with a strong PD-L1 expression status were evaluated for OS. PD-L1 expression was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50%. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months. Participant data were censored at last assessment.
Outcome measures
| Measure |
Pembrolizumab
n=44 Participants
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
|
|---|---|
|
Overall Survival (OS) in Strong Programmed Cell Death Ligand 1 (PD-L1) Positive Participants
|
6.9 Months
Interval 4.0 to 11.8
|
Adverse Events
Pembrolizumab
Serious events: 87 serious events
Other events: 158 other events
Deaths: 153 deaths
Pembrolizumab Second Course
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=171 participants at risk
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
|
Pembrolizumab Second Course
n=3 participants at risk
Participants who met the criteria for re-treatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 1 year of treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/171 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
3/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
3/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Cardiac disorders
Pericardial effusion
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Endocrine disorders
Hyperthyroidism
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Colitis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Dysphagia
|
1.8%
3/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.58%
1/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
3/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Vomiting
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Chills
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Death
|
1.8%
3/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Facial pain
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Malaise
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Oedema peripheral
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Pyrexia
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Swelling face
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Hepatobiliary disorders
Hepatitis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Immune system disorders
Hypersensitivity
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Cellulitis
|
1.8%
3/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Empyema
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Endocarditis bacterial
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Osteomyelitis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Pneumonia
|
8.8%
15/171 • Number of events 18 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Pneumonia escherichia
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Pneumonia staphylococcal
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Pseudomonas infection
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Sepsis
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Septic shock
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Soft tissue infection
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Tracheitis
|
0.58%
1/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Tracheobronchitis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Urinary tract infection
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Vascular device infection
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Wound infection
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Injury, poisoning and procedural complications
Fall
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Investigations
Clostridium test positive
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
5/171 • Number of events 6 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.9%
5/171 • Number of events 5 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.58%
1/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
3/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Altered state of consciousness
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Dizziness
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Headache
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Seizure
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Spinal cord compression
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Syncope
|
2.3%
4/171 • Number of events 4 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Product Issues
Device dislocation
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Psychiatric disorders
Completed suicide
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Psychiatric disorders
Mental status changes
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.8%
3/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
4/171 • Number of events 4 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
4.7%
8/171 • Number of events 8 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
3/171 • Number of events 3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
4/171 • Number of events 4 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Vascular disorders
Deep vein thrombosis
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Vascular disorders
Hypotension
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
Other adverse events
| Measure |
Pembrolizumab
n=171 participants at risk
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 24 months. Participants who stopped pembrolizumab as a result of obtaining a CR or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for re-treatment.
|
Pembrolizumab Second Course
n=3 participants at risk
Participants who met the criteria for re-treatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 3-week cycle for up to 1 year of treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
8.8%
15/171 • Number of events 15 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.7%
32/171 • Number of events 35 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Endocrine disorders
Hypothyroidism
|
18.7%
32/171 • Number of events 34 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
9/171 • Number of events 13 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Constipation
|
24.6%
42/171 • Number of events 46 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
24/171 • Number of events 38 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
12/171 • Number of events 12 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Dysphagia
|
13.5%
23/171 • Number of events 24 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/171 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.58%
1/171 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Gastrointestinal disorders
Nausea
|
19.9%
34/171 • Number of events 37 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Fatigue
|
39.2%
67/171 • Number of events 71 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Oedema peripheral
|
6.4%
11/171 • Number of events 13 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
General disorders
Pyrexia
|
5.8%
10/171 • Number of events 11 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Herpes zoster
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Infections and infestations
Pneumonia
|
7.0%
12/171 • Number of events 15 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
9/171 • Number of events 10 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Injury, poisoning and procedural complications
Stoma site erythema
|
0.00%
0/171 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Investigations
Alanine aminotransferase increased
|
6.4%
11/171 • Number of events 13 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
19/171 • Number of events 20 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
9/171 • Number of events 9 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Investigations
Lymphocyte count decreased
|
5.8%
10/171 • Number of events 10 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Investigations
Weight decreased
|
19.3%
33/171 • Number of events 33 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.5%
30/171 • Number of events 36 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.4%
16/171 • Number of events 20 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.6%
13/171 • Number of events 15 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.2%
14/171 • Number of events 23 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.4%
11/171 • Number of events 16 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.4%
11/171 • Number of events 13 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.58%
1/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.4%
11/171 • Number of events 16 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.2%
14/171 • Number of events 17 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
17.0%
29/171 • Number of events 41 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.8%
27/171 • Number of events 33 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
9/171 • Number of events 9 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.6%
13/171 • Number of events 13 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.6%
13/171 • Number of events 14 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Dizziness
|
10.5%
18/171 • Number of events 21 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Headache
|
11.7%
20/171 • Number of events 20 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
9/171 • Number of events 9 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Psychiatric disorders
Depression
|
4.1%
7/171 • Number of events 7 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Psychiatric disorders
Insomnia
|
10.5%
18/171 • Number of events 19 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
38/171 • Number of events 39 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.5%
23/171 • Number of events 26 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.3%
4/171 • Number of events 4 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
14/171 • Number of events 14 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/171 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.9%
17/171 • Number of events 20 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.5%
6/171 • Number of events 7 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Vascular disorders
Hypertension
|
6.4%
11/171 • Number of events 17 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Vascular disorders
Hypotension
|
9.4%
16/171 • Number of events 17 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
0.00%
0/3 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
|
Vascular disorders
Lymphoedema
|
1.2%
2/171 • Number of events 2 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
33.3%
1/3 • Number of events 1 • First Course: Up to 76.9 months Second Course: Up to 53.3 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses.
|
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