Trial Outcomes & Findings for Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)-China Extension Study (NCT NCT04716933)
NCT ID: NCT04716933
Last Updated: 2025-09-09
Results Overview
PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
201 participants
Primary outcome timeframe
Up to approximately 43 months
Results posted on
2025-09-09
Participant Flow
201 Chinese participants were randomized and received treatment as a part of global study \[NCT03829319; n=761\] or to the extension portion. No participants from China were randomized to Part 1.
Participant milestones
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
100
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
101
|
100
|
Reasons for withdrawal
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
|---|---|---|
|
Overall Study
Sponsor Decision
|
36
|
33
|
|
Overall Study
Death
|
65
|
67
|
Baseline Characteristics
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)-China Extension Study
Baseline characteristics by cohort
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
n=101 Participants
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
n=100 Participants
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
60.9 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
59.9 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG = 0
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG = 1
|
81 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline
TPS = < 50%
|
77 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline
TPS = ≥ 50%
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline
Not Evaluable
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Geographic Region
East Asia
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Geographic Region
Non-East Asia
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 43 monthsPopulation: All Chinese participants who were randomized to the global study (NCT03829319) or to the extension portion that were evaluable for response.
PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
Outcome measures
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
n=101 Participants
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
n=100 Participants
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
|---|---|---|
|
Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
15.3 Months
Interval 12.2 to 19.6
|
9.2 Months
Interval 8.2 to 12.5
|
PRIMARY outcome
Timeframe: Up to approximately 43 monthsPopulation: All Chinese participants who were randomized to the global study (NCT03829319) or to the extension portion that were evaluable for response.
OS is defined as the time from randomization to the time of death from any cause. OS is presented.
Outcome measures
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
n=101 Participants
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
n=100 Participants
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
|---|---|---|
|
Part 2: Overall Survival (OS)
|
26.6 Months
Interval 22.2 to 35.0
|
22.0 Months
Interval 16.6 to 24.8
|
SECONDARY outcome
Timeframe: Up to approximately 57 monthsPopulation: All Chinese participants who were randomized to the global study (NCT03829319) or to the extension portion that were evaluable for response.
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR as assessed per modified RECIST 1.1 will be presented.
Outcome measures
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
n=101 Participants
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
n=100 Participants
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
|---|---|---|
|
Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
70.3 Percentage of participants
Interval 60.4 to 79.0
|
59.0 Percentage of participants
Interval 48.7 to 68.7
|
SECONDARY outcome
Timeframe: Up to approximately 57 monthsPopulation: All Chinese participants who were randomized to the global study (NCT03829319) or to the extension portion that were evaluable for response.
For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed per modified RECIST 1.1 will be presented.
Outcome measures
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
n=62 Participants
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
n=51 Participants
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
|---|---|---|
|
Part 2: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
17.0 Months
Interval 12.6 to 23.6
|
12.5 Months
Interval 6.7 to 27.5
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All Chinese participants who were randomized to the global study (NCT03829319) or to the extension portion who received at least one dose of study treatment.
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one of more adverse events during Part 2 of this study were presented.
Outcome measures
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
n=101 Participants
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
n=100 Participants
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
|---|---|---|
|
Part 2: Number of Participants Who Experienced an Adverse Event (AE)
|
101 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All Chinese participants who were randomized to the global study (NCT03829319) or to the extension portion who received at least one dose of study treatment.
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment during Part 2 of this study were presented.
Outcome measures
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
n=101 Participants
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
n=100 Participants
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
|---|---|---|
|
Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
|
42 Participants
|
21 Participants
|
Adverse Events
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
Serious events: 67 serious events
Other events: 100 other events
Deaths: 65 deaths
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
Serious events: 53 serious events
Other events: 99 other events
Deaths: 67 deaths
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo(Second Course)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
n=101 participants at risk
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
n=100 participants at risk
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo(Second Course)
n=2 participants at risk
Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to \~1 year. Participants previously receiving placebo could continue receiving placebo at investigator's discretion.
|
|---|---|---|---|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
6/101 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
3.0%
3/100 • Number of events 4 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
3/101 • Number of events 4 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Cardiac disorders
Coronary artery disease
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
2.0%
2/100 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Cardiac disorders
Myocardial infarction
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Cardiac disorders
Myocarditis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Endocrine disorders
Adrenal haematoma
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Eye disorders
Cataract
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
2.0%
2/100 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Constipation
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Diarrhoea
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Nausea
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
2.0%
2/100 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Stomatitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Subileus
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Asthenia
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Chest pain
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
2.0%
2/100 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Death
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Fatigue
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Malaise
|
3.0%
3/101 • Number of events 3 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Oedema
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Hepatobiliary disorders
Hepatic failure
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Hepatobiliary disorders
Hepatitis
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
3.0%
3/100 • Number of events 3 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Bronchitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
COVID-19
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Febrile infection
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Osteomyelitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Pneumonia
|
11.9%
12/101 • Number of events 13 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
16.0%
16/100 • Number of events 18 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
50.0%
1/2 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
2.0%
2/100 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Sepsis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Tuberculosis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
2.0%
2/100 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Injury, poisoning and procedural complications
Fracture
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
5/101 • Number of events 5 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
6.0%
6/100 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Amylase increased
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
5/101 • Number of events 5 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
3.0%
3/100 • Number of events 3 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Blood creatinine increased
|
4.0%
4/101 • Number of events 5 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Lymphocyte count decreased
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Neutrophil count decreased
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
4.0%
4/100 • Number of events 4 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Platelet count decreased
|
6.9%
7/101 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
4.0%
4/100 • Number of events 4 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
White blood cell count decreased
|
3.0%
3/101 • Number of events 4 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
3/101 • Number of events 4 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
2.0%
2/100 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Nervous system disorders
Basal ganglia infarction
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Nervous system disorders
Cerebral infarction
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Nervous system disorders
Cerebrovascular accident
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Renal and urinary disorders
Renal failure
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Renal and urinary disorders
Renal tubular injury
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Reproductive system and breast disorders
Prostatitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.0%
3/101 • Number of events 3 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
3.0%
3/100 • Number of events 3 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
3.0%
3/100 • Number of events 3 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
3/101 • Number of events 3 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
6.0%
6/100 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.9%
7/101 • Number of events 7 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
8.0%
8/100 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
4.0%
4/100 • Number of events 4 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Dermatitis herpetiformis
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Eye disorders
Retinal detachment
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.0%
2/101 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/101 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
Other adverse events
| Measure |
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
n=101 participants at risk
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
n=100 participants at risk
Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
|
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo(Second Course)
n=2 participants at risk
Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to \~1 year. Participants previously receiving placebo could continue receiving placebo at investigator's discretion.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
16.8%
17/101 • Number of events 31 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
17.0%
17/100 • Number of events 21 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
50.0%
1/2 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Blood and lymphatic system disorders
Anaemia
|
83.2%
84/101 • Number of events 266 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
82.0%
82/100 • Number of events 224 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
5/101 • Number of events 9 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
10.0%
10/100 • Number of events 14 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Endocrine disorders
Hyperthyroidism
|
5.9%
6/101 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
7.0%
7/100 • Number of events 7 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Endocrine disorders
Hypothyroidism
|
24.8%
25/101 • Number of events 43 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
14.0%
14/100 • Number of events 17 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
6/101 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
6.0%
6/100 • Number of events 9 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.9%
9/101 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
3.0%
3/100 • Number of events 4 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Constipation
|
25.7%
26/101 • Number of events 44 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
41.0%
41/100 • Number of events 55 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Diarrhoea
|
18.8%
19/101 • Number of events 36 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
13.0%
13/100 • Number of events 16 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Gingival pain
|
8.9%
9/101 • Number of events 14 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Mouth ulceration
|
13.9%
14/101 • Number of events 14 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
7.0%
7/100 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Nausea
|
33.7%
34/101 • Number of events 91 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
35.0%
35/100 • Number of events 67 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
6/101 • Number of events 9 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
2.0%
2/100 • Number of events 2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Toothache
|
9.9%
10/101 • Number of events 14 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
6.0%
6/100 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Gastrointestinal disorders
Vomiting
|
22.8%
23/101 • Number of events 32 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
19.0%
19/100 • Number of events 24 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Asthenia
|
14.9%
15/101 • Number of events 21 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
10.0%
10/100 • Number of events 19 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Chest discomfort
|
9.9%
10/101 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
9.0%
9/100 • Number of events 9 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Chest pain
|
5.0%
5/101 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
13.0%
13/100 • Number of events 15 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Fatigue
|
22.8%
23/101 • Number of events 27 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
17.0%
17/100 • Number of events 27 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Malaise
|
5.0%
5/101 • Number of events 7 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
6.0%
6/100 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
General disorders
Oedema peripheral
|
7.9%
8/101 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
12.0%
12/100 • Number of events 26 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
COVID-19
|
11.9%
12/101 • Number of events 14 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
10.0%
10/100 • Number of events 10 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Pneumonia
|
10.9%
11/101 • Number of events 13 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
6.0%
6/100 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Upper respiratory tract infection
|
15.8%
16/101 • Number of events 24 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
13.0%
13/100 • Number of events 18 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Infections and infestations
Urinary tract infection
|
4.0%
4/101 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
7.0%
7/100 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Alanine aminotransferase increased
|
62.4%
63/101 • Number of events 191 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
58.0%
58/100 • Number of events 183 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Amylase increased
|
20.8%
21/101 • Number of events 35 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
18.0%
18/100 • Number of events 31 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
50.0%
1/2 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Aspartate aminotransferase increased
|
66.3%
67/101 • Number of events 226 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
61.0%
61/100 • Number of events 188 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Bilirubin conjugated increased
|
8.9%
9/101 • Number of events 13 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
5.0%
5/100 • Number of events 7 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Blood alkaline phosphatase increased
|
21.8%
22/101 • Number of events 44 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
18.0%
18/100 • Number of events 29 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Blood bilirubin increased
|
13.9%
14/101 • Number of events 20 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
7.0%
7/100 • Number of events 10 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Blood creatinine increased
|
27.7%
28/101 • Number of events 65 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
22.0%
22/100 • Number of events 45 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Blood lactate dehydrogenase increased
|
15.8%
16/101 • Number of events 46 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
10.0%
10/100 • Number of events 16 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Blood thyroid stimulating hormone increased
|
13.9%
14/101 • Number of events 20 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
3.0%
3/100 • Number of events 5 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Blood urea increased
|
5.9%
6/101 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
4.0%
4/100 • Number of events 5 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Blood uric acid increased
|
6.9%
7/101 • Number of events 14 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
5.0%
5/100 • Number of events 7 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Electrocardiogram QT prolonged
|
6.9%
7/101 • Number of events 9 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
6.0%
6/100 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Fibrin D dimer increased
|
10.9%
11/101 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
3.0%
3/100 • Number of events 3 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Gamma-glutamyltransferase increased
|
36.6%
37/101 • Number of events 69 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
34.0%
34/100 • Number of events 51 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Lipase increased
|
13.9%
14/101 • Number of events 21 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
11.0%
11/100 • Number of events 12 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Lymphocyte count decreased
|
20.8%
21/101 • Number of events 52 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
12.0%
12/100 • Number of events 28 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Neutrophil count decreased
|
82.2%
83/101 • Number of events 401 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
74.0%
74/100 • Number of events 326 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Platelet count decreased
|
64.4%
65/101 • Number of events 248 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
47.0%
47/100 • Number of events 140 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Urinary occult blood positive
|
6.9%
7/101 • Number of events 9 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
6.0%
6/100 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
50.0%
1/2 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Weight decreased
|
28.7%
29/101 • Number of events 37 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
14.0%
14/100 • Number of events 16 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
Weight increased
|
19.8%
20/101 • Number of events 30 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
7.0%
7/100 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Investigations
White blood cell count decreased
|
77.2%
78/101 • Number of events 366 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
70.0%
70/100 • Number of events 293 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.6%
38/101 • Number of events 89 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
44.0%
44/100 • Number of events 78 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.7%
26/101 • Number of events 61 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
16.0%
16/100 • Number of events 43 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.9%
11/101 • Number of events 18 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
4.0%
4/100 • Number of events 7 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
7.9%
8/101 • Number of events 10 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
2.0%
2/100 • Number of events 7 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
11.9%
12/101 • Number of events 73 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
13.0%
13/100 • Number of events 46 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.9%
15/101 • Number of events 31 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
13.0%
13/100 • Number of events 35 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.7%
34/101 • Number of events 78 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
25.0%
25/100 • Number of events 62 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.9%
14/101 • Number of events 27 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
7.0%
7/100 • Number of events 19 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
8.9%
9/101 • Number of events 22 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
7.0%
7/100 • Number of events 8 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.8%
19/101 • Number of events 40 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
18.0%
18/100 • Number of events 25 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
24.8%
25/101 • Number of events 51 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
15.0%
15/100 • Number of events 26 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.9%
12/101 • Number of events 27 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
5.0%
5/100 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
11.9%
12/101 • Number of events 14 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
9.0%
9/100 • Number of events 20 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
50.0%
1/2 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
9/101 • Number of events 9 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
5.0%
5/100 • Number of events 5 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
3/101 • Number of events 3 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
14.0%
14/100 • Number of events 18 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.9%
8/101 • Number of events 17 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
9.0%
9/100 • Number of events 10 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Nervous system disorders
Dizziness
|
9.9%
10/101 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
13.0%
13/100 • Number of events 21 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Nervous system disorders
Headache
|
7.9%
8/101 • Number of events 10 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
9.0%
9/100 • Number of events 13 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Psychiatric disorders
Insomnia
|
6.9%
7/101 • Number of events 10 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
13.0%
13/100 • Number of events 22 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Renal and urinary disorders
Albuminuria
|
7.9%
8/101 • Number of events 27 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
4.0%
4/100 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Renal and urinary disorders
Haematuria
|
6.9%
7/101 • Number of events 19 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
7.0%
7/100 • Number of events 12 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Renal and urinary disorders
Proteinuria
|
32.7%
33/101 • Number of events 75 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
23.0%
23/100 • Number of events 35 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.8%
17/101 • Number of events 24 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
14.0%
14/100 • Number of events 18 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.9%
13/101 • Number of events 16 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
10.0%
10/100 • Number of events 10 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.9%
12/101 • Number of events 28 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
3.0%
3/100 • Number of events 4 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.9%
7/101 • Number of events 9 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
5.0%
5/100 • Number of events 5 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.9%
9/101 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
6.0%
6/100 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.9%
7/101 • Number of events 7 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
1.0%
1/100 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.9%
13/101 • Number of events 15 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
11.0%
11/100 • Number of events 11 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
4/101 • Number of events 5 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
10.0%
10/100 • Number of events 18 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.8%
19/101 • Number of events 28 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
14.0%
14/100 • Number of events 15 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/2 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Vascular disorders
Hypertension
|
33.7%
34/101 • Number of events 51 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
5.0%
5/100 • Number of events 6 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
50.0%
1/2 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
|
Cardiac disorders
Degenerative aortic valve disease
|
0.99%
1/101 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
0.00%
0/100 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
50.0%
1/2 • Number of events 1 • Up to approximately 42 months for first course and up to approximately 57 months for second course. All-cause mortality (ACM): Up to approximately 57 months for first and second course.
All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs
|
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 will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER