Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer/ Extensive-disease Small Cell Lung Cancer (MK-3475-011/KEYNOTE-011) (NCT NCT01840579)
NCT ID: NCT01840579
Last Updated: 2021-06-22
Results Overview
The following toxicities graded per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0) were considered DLTs if judged by the investigator to be related to either study drug: * Grade (G) 4 neutropenia lasting \>7 days * Grade 3 and Grade 4 febrile neutropenia * Grade 4 thrombocytopenia (\<25,000/mm\^3) * Grade 4 anemia * Grade 4 non-hematologic toxicity (not laboratory) * Grade 3 non-hematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care * Any Grade 3 non-hematologic laboratory value if medical intervention is required to treat the participant or the abnormality persists for \>7 days. * (Part D only) Missing the second dose of pembrolizumab (Cycle1 Day 22) due to drug-related adverse event
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
Cycle 1 (first dose and up to 4 weeks in Part A, 3 weeks in Parts B, C, E, and 6 weeks in Part D)
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
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|---|---|---|---|---|---|---|---|---|---|---|
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Overall Study
STARTED
|
3
|
7
|
6
|
6
|
8
|
6
|
6
|
6
|
6
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
4
|
3
|
4
|
2
|
4
|
3
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
2
|
3
|
4
|
4
|
2
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
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|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Status not recorded
|
0
|
0
|
2
|
3
|
4
|
3
|
0
|
3
|
3
|
3
|
|
Overall Study
Progressive disease
|
3
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Ongoing in study
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Follow-up ended by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer/ Extensive-disease Small Cell Lung Cancer (MK-3475-011/KEYNOTE-011)
Baseline characteristics by cohort
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=6 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=6 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=8 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel
n=6 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=6 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG = 1
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
39 Participants
n=95 Participants
|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 6.4 • n=93 Participants
|
64.3 Years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
57.3 Years
STANDARD_DEVIATION 15.4 • n=27 Participants
|
70.0 Years
STANDARD_DEVIATION 6.0 • n=483 Participants
|
66.6 Years
STANDARD_DEVIATION 8.2 • n=36 Participants
|
65.2 Years
STANDARD_DEVIATION 11.8 • n=10 Participants
|
66.0 Years
STANDARD_DEVIATION 6.9 • n=115 Participants
|
64.0 Years
STANDARD_DEVIATION 3.6 • n=40 Participants
|
64.7 Years
STANDARD_DEVIATION 11.8 • n=8 Participants
|
60.7 Years
STANDARD_DEVIATION 8.1 • n=62 Participants
|
64.4 Years
STANDARD_DEVIATION 9.9 • n=95 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
14 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
43 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
57 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
57 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG = 0
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
18 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (first dose and up to 4 weeks in Part A, 3 weeks in Parts B, C, E, and 6 weeks in Part D)Population: The DLT analysis set included all participants who received at least at least 90% of the prescribed dose of pembrolizumab and the combination regimen and were evaluable for DLTs in the DLT evaluation period.
The following toxicities graded per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0) were considered DLTs if judged by the investigator to be related to either study drug: * Grade (G) 4 neutropenia lasting \>7 days * Grade 3 and Grade 4 febrile neutropenia * Grade 4 thrombocytopenia (\<25,000/mm\^3) * Grade 4 anemia * Grade 4 non-hematologic toxicity (not laboratory) * Grade 3 non-hematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care * Any Grade 3 non-hematologic laboratory value if medical intervention is required to treat the participant or the abnormality persists for \>7 days. * (Part D only) Missing the second dose of pembrolizumab (Cycle1 Day 22) due to drug-related adverse event
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=6 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=6 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=6 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=6 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=6 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=6 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 51.3 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=6 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=6 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=8 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=6 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=6 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event (AE)
|
3 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 37.9 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=6 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=6 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=8 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=6 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=6 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At designated timepoints in Cycle 1 for Parts A, B, C, D, and E (up to approximately 22 days)Population: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Parts A, B, C, D, and E Cycle 1.
Cmax was the maximum observed concentration of pembrolizumab in serum. For Part A, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), 6 hour (hr) (±30 min), and 24hr; Days 2, 3, 8, 15, and 22 (±2 hr for Day 2 to Day 22) after completion of infusion. For Parts B, C, and E, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), and Day 15 (±24 hr) after completion of infusion. For Part D, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), Day 15, and Day 22 (±24 hr) after completion of infusion. Cycle 1 length for Part A was 28 days. Cycle 1 length for Parts B, C, and E was 21 days. Cycle 1 length for Part D was 42 days. Cmax is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for Cmax was planned for Parts A, B, C, D, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=6 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=6 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=8 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=6 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=6 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 1: Parts A, B, C, D, and E
|
47.4 µg/mL
Geometric Coefficient of Variation 19
|
250 µg/mL
Geometric Coefficient of Variation 23
|
52.51 µg/mL
Geometric Coefficient of Variation 24.44
|
47.46 µg/mL
Geometric Coefficient of Variation 17.04
|
56.39 µg/mL
Geometric Coefficient of Variation 18.88
|
53.79 µg/mL
Geometric Coefficient of Variation 14.18
|
72.71 µg/mL
Geometric Coefficient of Variation 10.12
|
74.33 µg/mL
Geometric Coefficient of Variation 14.04
|
84.55 µg/mL
Geometric Coefficient of Variation 7.38
|
88.65 µg/mL
Geometric Coefficient of Variation 19.14
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 pre- and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 2.
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 2 at pre-dose and 0-30 minutes post-dose. Cycle 2 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 2 was only planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=6 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 2: Part A
|
82.7 µg/mL
Geometric Coefficient of Variation 12
|
322 µg/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 Day 1 pre- and post-dose (Part A) and Day 22 pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and post-dose (Part D)Population: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Cycle 4 Parts A and D.
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 4 at pre-dose and 0-30 minutes post-dose and for Part D on Day 22 of Cycle 4 at pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and 0-30 minutes post-dose. Cycle 4 length for Part A was 14 days. Cycle 4 length for Part D was 42 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 4 was only planned for Parts A and D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=2 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=3 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=3 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 4: Parts A and D
|
93.0 µg/mL
Geometric Coefficient of Variation 44
|
367 µg/mL
Geometric Coefficient of Variation 35
|
86.21 µg/mL
Geometric Coefficient of Variation 3.59
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 6 Day 1 pre- and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 6.
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 6 at pre-dose and 0-30 minutes post-dose. Cycle 6 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 6 was only planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=2 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=2 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 6: Part A
|
115 µg/mL
Geometric Coefficient of Variation 15
|
286 µg/mL
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 8 Day 1 pre- and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Parts A, B, C, and E Cycle 8. There were no participants that contributed data for the analysis of Cmax for the Pembrolizumab+Cisplatin/Etoposide+G-CSF arm in Part E of Cycle 8.
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Parts A, B, C and E on Day 1 of Cycle 8 at pre-dose and 0-30 minutes post-dose. Cycle 8 length for Part A was 14 days. Cycle 8 length for Parts B, C, and E was 21 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 8 was only planned for Parts A, B, C, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=2 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=2 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=3 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=1 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=2 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=1 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 8: Parts A, B, C, and E
|
115 µg/mL
Geometric Coefficient of Variation 15
|
298 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
124.47 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
95.51 µg/mL
Geometric Coefficient of Variation 17.38
|
122.00 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
66.62 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
150.00 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
131.78 µg/mL
Geometric Coefficient of Variation 9.46
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 10 Day 1 pre- and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 10.
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 10 at pre-dose and 0-30 minutes post-dose. Cycle 10 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 10 was only planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 10: Part A
|
133 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
266 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 12 Day 1 pre- and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 12. There were no participants that contributed data for the analysis of Cmax for the 2 mg/kg arm in Part A of Cycle 12.
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 12 at pre-dose and 0-30 minutes post-dose. Cycle 12 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 12 was only planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 12: Part A
|
—
|
357 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 14 Day 1 pre- and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 14. There were no participants that contributed data for the analysis of Cmax for the 2 mg/kg arm in Part A of Cycle 14.
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 14 at pre-dose and 0-30 minutes post-dose. Cycle 14 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 14 was only planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 14: Part A
|
—
|
335 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 16 Day 1 pre- and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 16. There were no participants that contributed data for the analysis of Cmax for the 2 mg/kg arm in Part A of Cycle 16.
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 16 at pre-dose and 0-30 minutes post-dose. Cycle 16 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 16 was only planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 16: Part A
|
—
|
348 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 18 Day 1 pre- and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 18. There were no participants that contributed data for the analysis of Cmax for the 2 mg/kg arm in Part A of Cycle 18.
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 18 at pre-dose and 0-30 minutes post-dose. Cycle 18 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 18 was only planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 18: Part A
|
—
|
329 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At designated timepoints in Cycle 1 for Parts A, B, C, D, and E (up to approximately 22 days)Population: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Tmax in Parts A, B, C, D, and E Cycle 1.
Tmax was the time required to reach the maximum concentration of pembrolizumab in serum. For Part A, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), 6 hour (hr) (±30 min), and 24hr; Days 2, 3, 8, 15, and 22 (±2 hr for Day 2 to Day 22) after completion of infusion. For Parts B, C, and E, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), and Day 15 (±24 hr) after completion of infusion. For Part D, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), Day 15, and Day 22 (±24 hr) after completion of infusion. Cycle 1 length for Part A was 28 days. Cycle 1 length for Parts B, C, and E was 21 days. Cycle 1 length for Part D was 42 days. Tmax is reported as median and full range. Per protocol, analysis for Tmax in Cycle 1 was planned for Parts A, B, C, D, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=6 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=6 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=8 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=6 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=6 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Serum Concentration (Tmax) of Pembrolizumab for Cycle 1: Parts A, B, C, D, and E
|
0.223 days
Interval 0.00208 to 0.233
|
0.00903 days
Interval 0.000694 to 0.232
|
1.98 days
Interval 0.94 to 4.94
|
2.52 days
Interval 0.033 to 13.91
|
0.028 days
Interval 0.025 to 1.08
|
0.027 days
Interval 0.022 to 1.02
|
0.026 days
Interval 0.024 to 0.029
|
0.026 days
Interval 0.026 to 0.029
|
0.028 days
Interval 0.023 to 0.041
|
0.031 days
Interval 0.025 to 0.033
|
SECONDARY outcome
Timeframe: Cycle 4 Day 22 pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for Tmax in the Cycle 4 analysis of Part D.
Tmax was the time required to reach the maximum concentration of pembrolizumab in serum. Blood sampling was taken for Part D on Day 22 of Cycle 4 at pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and 0-30 minutes post-dose. Cycle length for Part D was 42 days. Tmax is reported as median and full range. Per protocol, analysis for Tmax in Cycle 4 was only planned for Part D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Serum Concentration (Tmax) of Pembrolizumab for Cycle 4: Part D
|
0.026 days
Interval 0.025 to 0.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 8 Day 1 pre- and post-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Tmax in Parts B, C, and E Cycle 8. There were no participants that contributed data available for the analysis of Tmax for the Pembrolizumab+Cisplatin/Etoposide+G-CSF arm in Part E of Cycle 8.
Tmax was the time required to reach the maximum concentration of pembrolizumab in serum. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 8 at pre-dose and 0-30 minutes post-dose. Cycle 8 for Parts B, C, and E was 21 days. Tmax is reported as median and full range. Per protocol, analysis for Tmax in Cycle 8was planned for Parts B, C, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=2 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=3 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=1 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=2 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=1 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=3 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Serum Concentration (Tmax) of Pembrolizumab for Cycle 8: Parts B, C, and E
|
0.024 days
Interval 0.022 to 0.025
|
0.026 days
Interval 0.025 to 0.026
|
0.028 days
Interval 0.028 to 0.028
|
0.027 days
Interval 0.024 to 0.029
|
0.029 days
Interval 0.029 to 0.029
|
0.026 days
Interval 0.023 to 0.031
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 1 Ctrough in Parts A, B, C, D, and E.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 1 Ctrough was taken for Parts A, B, C, D, and E on Day 1 of Cycle 2 at pre-dose (prior to Cycle 2 infusion). Cycle 1 length for Part A was 28 days. Cycle 1 length for Parts B, C, and E was 21 days. Cycle 1 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 1 Ctrough was planned for Parts A, B, C, D, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=6 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=6 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=6 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=6 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=6 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=3 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=5 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=6 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 1: Parts A, B, C, D, and E
|
11.2 µg/mL
Geometric Coefficient of Variation 51
|
47.9 µg/mL
Geometric Coefficient of Variation 50
|
19.88 µg/mL
Geometric Coefficient of Variation 46.61
|
15.79 µg/mL
Geometric Coefficient of Variation 33.24
|
9.45 µg/mL
Geometric Coefficient of Variation 31.31
|
10.96 µg/mL
Geometric Coefficient of Variation 17.19
|
8.26 µg/mL
Geometric Coefficient of Variation 16.20
|
14.57 µg/mL
Geometric Coefficient of Variation 10.56
|
15.30 µg/mL
Geometric Coefficient of Variation 19.82
|
17.88 µg/mL
Geometric Coefficient of Variation 9.58
|
SECONDARY outcome
Timeframe: Cycle 2 Day 22 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 2 Ctrough in Part D.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 2 Ctrough was taken for Part D on Day 22 of Cycle 2 at pre-dose (prior to Cycle 3 infusion). Cycle 2 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 2 Ctrough was only planned for Part D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=5 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 2: Part D
|
20.10 µg/mL
Geometric Coefficient of Variation 24.59
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 3 Day 22 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 3 Ctrough in Part D.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 3 Ctrough was taken for Part D on Day 22 of Cycle 3 at pre-dose (prior to Cycle 4 infusion). Cycle 3 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV).
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=4 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 3: Part D
|
30.30 µg/mL
Geometric Coefficient of Variation 19.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 Day 1 at Pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 3 Ctrough in Parts A, B, C, and E.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 3 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 4 at pre-dose (prior to Cycle 4 infusion). Cycle 3 length for Part A was 14 days. Cycle 3 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV).
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=2 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=4 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=5 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=4 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=3 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=4 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=4 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=5 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 3: Parts A, B, C, and E
|
37.2 µg/mL
Geometric Coefficient of Variation 13
|
83.0 µg/mL
Geometric Coefficient of Variation 265
|
32.71 µg/mL
Geometric Coefficient of Variation 30.35
|
25.38 µg/mL
Geometric Coefficient of Variation 22.12
|
24.80 µg/mL
Geometric Coefficient of Variation 9.28
|
23.63 µg/mL
Geometric Coefficient of Variation 4.79
|
32.20 µg/mL
Geometric Coefficient of Variation 21.52
|
30.43 µg/mL
Geometric Coefficient of Variation 25.67
|
34.31 µg/mL
Geometric Coefficient of Variation 22.05
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 Day 22 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 4 Ctrough in Part D.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 4 Ctrough was taken for Part D on Day 22 of Cycle 4 at pre-dose (prior to Cycle 5 infusion). Cycle 4 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 4 Ctrough was only planned for Part D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=4 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 4: Part D
|
28.08 µg/mL
Geometric Coefficient of Variation 23.62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 6 Day 1 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 5 Ctrough in Parts A, B, C, and E.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 5 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 6 at pre-dose (prior to Cycle 6 infusion). Cycle 5 length for Part A was 14 days. Cycle 5 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 5 Ctrough was only planned for Parts A, B, C, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=2 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=3 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=4 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=4 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=3 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=4 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=3 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=4 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=2 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 5: Parts A, B, C, and E
|
46.5 µg/mL
Geometric Coefficient of Variation 12
|
38.3 µg/mL
Geometric Coefficient of Variation 1640
|
37.70 µg/mL
Geometric Coefficient of Variation 7.95
|
23.84 µg/mL
Geometric Coefficient of Variation 69.26
|
35.33 µg/mL
Geometric Coefficient of Variation 16.60
|
33.91 µg/mL
Geometric Coefficient of Variation 14.66
|
47.82 µg/mL
Geometric Coefficient of Variation 14.28
|
38.63 µg/mL
Geometric Coefficient of Variation 25.56
|
46.47 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
SECONDARY outcome
Timeframe: Cycle 6 Day 22 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 6 Ctrough in Part D.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 6 Ctrough was taken for Part D on Day 22 of Cycle 6 at pre-dose (prior to Cycle 7 infusion). Cycle 6 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 6 Ctrough was only planned for Part D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 6: Part D
|
40.10 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 8 Day 1 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 7 Ctrough in Parts A, B, C, and E.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 7 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 8 at pre-dose (prior to Cycle 8 infusion). Cycle 7 length for Part A was 14 days. Cycle 7 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 7 Ctrough was only planned for Parts A, B, C, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=2 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=2 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=3 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=1 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=4 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=1 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=3 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=1 Participants
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 7: Parts A, B, C, and E
|
54.9 µg/mL
Geometric Coefficient of Variation 13
|
134 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
39.33 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
37.44 µg/mL
Geometric Coefficient of Variation 8.87
|
42.70 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
32.44 µg/mL
Geometric Coefficient of Variation 29.15
|
54.0 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
48.92 µg/mL
Geometric Coefficient of Variation 15.61
|
43.10 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 8 Day 22 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 8 Ctrough in Part D.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 8 Ctrough was taken for Part D on Day 22 of Cycle 8 at pre-dose (prior to Cycle 9 infusion). Cycle 8 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 8 Ctrough was only planned for Part D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 8: Part D
|
35.20 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 10 Day 1 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 9 Ctrough in Part A.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 9 Ctrough was taken for Part A on Day 1 of Cycle 10 at pre-dose (prior to Cycle 10 infusion). Cycle 9 length for Part A was 14 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 9 Ctrough was only planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 9: Part A
|
68.4 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
125 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 10 Day 22 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 10 Ctrough in Part D.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 10 Ctrough was taken for Part D on Day 22 of Cycle 10 at pre-dose (prior to Cycle 11 infusion). Cycle 10 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 10 Ctrough was only planned for Part D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 10: Part D
|
36.30 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 12 Day 1 Pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 11 Ctrough in Parts A, B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part A 2 mg/kg arm and Part E Pembrolizumab+Carboplatin/Etoposide and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 11 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 12 at pre-dose (prior to Cycle 12 infusion). Cycle 11 length for Part A was 14 days. Cycle 11 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 11 Ctrough was only planned for Parts A, B, C, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=1 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=3 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=1 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
n=1 Participants
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=1 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 11: Parts A, B, C, and E
|
—
|
159 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
39.30 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
45.00 µg/mL
Geometric Coefficient of Variation 6.84
|
32.60 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
57.80 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
52.20 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 12 Day 22 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 12 Ctrough in Part D.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 12 Ctrough was taken for Part D on Day 22 of Cycle 12 at pre-dose (prior to Cycle 13 infusion). Cycle 12 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 12 Ctrough was only planned for Part D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 12: Part D
|
30.90 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 14 Day 1 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 13 Ctrough in Part A. There were no participants that contributed data for the analysis of Ctrough for the Part A 2 mg/kg arm.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 13 Ctrough was taken for Part A on Day 1 of Cycle 14 at pre-dose (prior to Cycle 14 infusion). Cycle 13 length for Part A was 14 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 13 Ctrough was only planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 13: Part A
|
—
|
147 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 14 Day 22 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 14 Ctrough in Part D.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 14 Ctrough was taken for Part D on Day 22 of Cycle 14 at pre-dose (prior to Cycle 15 infusion). Cycle 14 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 14 Ctrough was only planned for Part D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 14: Part D
|
28.40 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 16 Day 1 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 15 Ctrough in Parts A, B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part A 2 mg/kg arm; Part C Pembrolizumab+Carboplatin/Paclitaxel and Pembrolizumab+Carboplatin/Nab-paclitaxel arms; and Part E Pembrolizumab+Carboplatin/Etoposide and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts A, B, C, and E on Day 1 of Cycle 16 at pre-dose (prior to Cycle 16 infusion). Cycle 15 length for Part A was 14 days. Cycle 15 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 15 Ctrough was only planned for Parts A, B, C, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=1 Participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=2 Participants
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=1 Participants
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 15: Parts A, B, C, and E
|
—
|
199 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
47.50 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
56.27 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
52.50 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 16 Day 22 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 16 Ctrough in Part D.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 16 Ctrough was taken for Part D on Day 22 of Cycle 16 at pre-dose (prior to Cycle 17 infusion). Cycle 16 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 16 Ctrough was only planned for Part D.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 16: Part D
|
30.70 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 18 Day 1 pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 17 Ctrough in Part A. There were no participants that contributed data for the analysis of Ctrough for the Part A 2 mg/kg arm.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Part A on Day 1 of Cycle 18 at pre-dose (prior to Cycle 18 infusion). Cycle 17 length for Part A was 14 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 17 Ctrough was planned for Part A.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 17: Part A
|
—
|
125 µg/mL
Geometric Coefficient of Variation NA
%CV cannot be calculated for 1 participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 20 Day 1 Pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 19 Ctrough in Parts B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part C Pembrolizumab+Carboplatin/Paclitaxel and Pembrolizumab+Carboplatin/Nab-paclitaxel arms; and Part E Pembrolizumab+Cisplatin/Etoposide, Pembrolizumab+Carboplatin/Etoposide, and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 20 at pre-dose (prior to Cycle 20 infusion). Cycle 19 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 19 Ctrough was only planned for Parts B, C, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=2 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 19: Parts B, C, and E
|
48.50 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
50.98 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 24 Day 1 Pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 23 Ctrough in Parts B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part C Pembrolizumab+Carboplatin/Paclitaxel and Pembrolizumab+Carboplatin/Nab-paclitaxel arms; and Part E Pembrolizumab+Cisplatin/Etoposide, Pembrolizumab+Carboplatin/Etoposide, and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 24 at pre-dose (prior to Cycle 24 infusion). Cycle 23 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 23 Ctrough was only planned for Parts B, C, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=2 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 23: Parts B, C, and E
|
42.40 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
51.72 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 28 Day 1 Pre-dosePopulation: The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 27 Ctrough in Parts B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part C Pembrolizumab+Carboplatin/Paclitaxel and Pembrolizumab+Carboplatin/Nab-paclitaxel arms; and Part E Pembrolizumab+Cisplatin/Etoposide, Pembrolizumab+Carboplatin/Etoposide, and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 28 at pre-dose (prior to Cycle 28 infusion). Cycle 27 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 27 Ctrough was only planned for Parts B, C, and E.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=1 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=1 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 27: Parts B, C, and E
|
53.90 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
68.20 µg/mL
Geometric Coefficient of Variation NA
%CV was not planned to be calculated for ≤2 participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)Population: The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for AUC 0-28 in Part A Cycle 1.
AUC 0-28 was the AUC of pembrolizumab from time zero to 28 days after dosing. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 pre-dose. Cycle 1 length was 28 days. AUC 0-28 is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for AUC 0-28 was only planned for Part A Cycle 1.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From 0-28 Days (AUC 0-28) for Part A Cycle 1
|
507 µg•day/mL
Geometric Coefficient of Variation 20
|
2219 µg•day/mL
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)Population: The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for AUC 0-inf in Part A Cycle 1.
AUC 0-inf was the AUC of pembrolizumab from time zero to infinity after dosing. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 pre-dose. Cycle 1 length was 28 days. AUC 0-inf is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for AUC 0-inf was only planned for Part A Cycle 1.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From 0-Infinity (AUC 0-inf) for Part A Cycle 1
|
812 µg•day/mL
Geometric Coefficient of Variation 45
|
3410 µg•day/mL
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)Population: The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for t1/2 in Part A Cycle 1.
t1/2 was the time required to divide the pembrolizumab concentration by two after reaching pseudo-equilibrium. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and pre-dose Day 1 of the following cycle prior to pembrolizumab infusion. Cycle 1 length A was 28 days. t1/2 is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for t1/2 was only planned for Part A Cycle 1.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of Pembrolizumab Over Time for Part A Cycle 1
|
18.4 days
Geometric Coefficient of Variation 56
|
18.1 days
Geometric Coefficient of Variation 68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)Population: The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for Vz in Part A Cycle 1.
Vz was the volume of distribution during the terminal phase. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 prior to pembrolizumab infusion. Cycle 1 length A was 28 days. Vz is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for Vz was only planned for Part A Cycle 1.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution (Vz) of Pembrolizumab Over Time for Part A Cycle 1
|
65.3 mL/kg
Geometric Coefficient of Variation 21
|
76.5 mL/kg
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)Population: The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for CL in Part A Cycle 1.
CL was the volume of plasma from which pembrolizumab was eliminated per unit time. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 prior to pembrolizumab infusion. Cycle 1 length A was 28 days. CL is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for CL was only planned for Part A Cycle 1.
Outcome measures
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 Participants
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 Participants
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance (CL) of Pembrolizumab Over Time for Part A Cycle 1
|
2.46 mL/day/kg
Geometric Coefficient of Variation 45
|
2.93 mL/day/kg
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Pembrolizumab 2 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Pembrolizumab 10 mg/kg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B: Pembrolizumab+Cisplatin/Pemetrexed
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Part B: Pembrolizumab+Carboplatin/Pemetrexed
Serious events: 5 serious events
Other events: 6 other events
Deaths: 5 deaths
Part C: Pembrolizumab+Carboplatin/Paclitaxel
Serious events: 3 serious events
Other events: 8 other events
Deaths: 5 deaths
Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Part D: Pembrolizumab+Ipilimumab
Serious events: 1 serious events
Other events: 5 other events
Deaths: 4 deaths
Part E: Pembrolizumab+Cisplatin/Etoposide
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Part E: Pembrolizumab+Carboplatin/Etoposide
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 participants at risk
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 participants at risk
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=6 participants at risk
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=6 participants at risk
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=8 participants at risk
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel
n=6 participants at risk
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=6 participants at risk
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=6 participants at risk
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=6 participants at risk
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
n=3 participants at risk
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
Other adverse events
| Measure |
Part A: Pembrolizumab 2 mg/kg
n=3 participants at risk
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part A: Pembrolizumab 10 mg/kg
n=7 participants at risk
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
|
Part B: Pembrolizumab+Cisplatin/Pemetrexed
n=6 participants at risk
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part B: Pembrolizumab+Carboplatin/Pemetrexed
n=6 participants at risk
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Paclitaxel
n=8 participants at risk
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel
n=6 participants at risk
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part D: Pembrolizumab+Ipilimumab
n=6 participants at risk
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
|
Part E: Pembrolizumab+Cisplatin/Etoposide
n=6 participants at risk
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Carboplatin/Etoposide
n=6 participants at risk
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
n=3 participants at risk
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
42.9%
3/7 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 14 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
4/8 • Number of events 6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 9 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
83.3%
5/6 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
2/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
4/6 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
4/6 • Number of events 7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
37.5%
3/8 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 10 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
2/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
4/6 • Number of events 10 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
4/6 • Number of events 10 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
4/8 • Number of events 8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 16 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 12 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 10 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
2/3 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
37.5%
3/8 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
83.3%
5/6 • Number of events 11 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
62.5%
5/8 • Number of events 9 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 20 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
83.3%
5/6 • Number of events 12 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 10 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
2/3 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
4/6 • Number of events 9 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
2/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
4/6 • Number of events 9 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
4/8 • Number of events 6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
3/3 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
42.9%
3/7 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
6/6 • Number of events 20 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
83.3%
5/6 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
37.5%
3/8 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
83.3%
5/6 • Number of events 7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
100.0%
3/3 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
2/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Extravasation
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
42.9%
3/7 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
4/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
4/8 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Oedema
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
42.9%
3/7 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
37.5%
3/8 • Number of events 6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Parotitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Infections and infestations
Wound infection
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Injury, poisoning and procedural complications
Breast injury
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
37.5%
3/8 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
4/8 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Blood cholesterol increased
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
QRS axis abnormal
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
42.9%
3/7 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
62.5%
5/8 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
4/6 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
2/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
4/6 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
62.5%
5/8 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
83.3%
5/6 • Number of events 5 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
66.7%
2/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
4/8 • Number of events 4 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar pustulosis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
28.6%
2/7 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
25.0%
2/8 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
14.3%
1/7 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
1/3 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
12.5%
1/8 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/7 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/8 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/6 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
0.00%
0/3 • Up to approximately 51.3 months
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER