Trial Outcomes & Findings for A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies (NCT NCT03829501)
NCT ID: NCT03829501
Last Updated: 2025-04-02
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An serious AE (SAE) was any AE that: * resulted in death; * was life-threatening; * resulted in inpatient hospitalization or prolongation of existing hospitalization; * resulted in a persistent or significant disability/incapacity; * resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs; * constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
222 participants
Primary outcome timeframe
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Results posted on
2025-04-02
Participant Flow
The study was conducted at 22 centers in 6 countries. A total of 222 participants, of which 0 were screen failures. Participants were enrolled from 28 January 2019 to 04 August 2023.
Participant milestones
| Measure |
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via intravenous (IV) infusion every 3 weeks (Q3W). The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed disease progression (PD) per immune-related (i) Response Evaluation Criteria in Solid Tumors (RECIST).
|
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative Breast Cancer (BC)
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Head and Neck Squamous Cell Carcinoma (HNSCC)
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
9
|
8
|
7
|
5
|
5
|
43
|
36
|
9
|
9
|
15
|
14
|
7
|
14
|
5
|
5
|
2
|
1
|
1
|
6
|
3
|
9
|
|
Overall Study
Treated
|
4
|
5
|
9
|
8
|
7
|
5
|
5
|
43
|
36
|
9
|
9
|
15
|
14
|
7
|
14
|
5
|
5
|
2
|
1
|
1
|
6
|
3
|
8
|
|
Overall Study
Safety Analysis Set
|
4
|
5
|
10
|
8
|
7
|
5
|
5
|
43
|
35
|
9
|
9
|
15
|
14
|
7
|
14
|
5
|
5
|
2
|
1
|
1
|
6
|
3
|
8
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
9
|
8
|
7
|
5
|
5
|
40
|
35
|
9
|
9
|
15
|
14
|
6
|
14
|
5
|
5
|
2
|
1
|
1
|
6
|
2
|
9
|
Reasons for withdrawal
| Measure |
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via intravenous (IV) infusion every 3 weeks (Q3W). The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed disease progression (PD) per immune-related (i) Response Evaluation Criteria in Solid Tumors (RECIST).
|
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative Breast Cancer (BC)
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Head and Neck Squamous Cell Carcinoma (HNSCC)
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal of Consent
|
2
|
0
|
3
|
0
|
1
|
1
|
0
|
10
|
10
|
3
|
4
|
4
|
4
|
0
|
3
|
0
|
1
|
1
|
0
|
0
|
3
|
0
|
1
|
|
Overall Study
PD
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
2
|
0
|
0
|
0
|
1
|
0
|
3
|
|
Overall Study
Lost to Follow Up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
2
|
0
|
2
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
2
|
4
|
5
|
6
|
5
|
4
|
5
|
24
|
22
|
6
|
3
|
10
|
10
|
5
|
7
|
2
|
2
|
1
|
1
|
1
|
1
|
2
|
3
|
|
Overall Study
Miscellaneous
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Ethnicity was not collected from any participant.
Baseline characteristics by cohort
| Measure |
Alomfilimab 0.8 mg
n=4 Participants
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg
n=5 Participants
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg
n=9 Participants
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg
n=8 Participants
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg
n=7 Participants
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 240 mg
n=5 Participants
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 0.8 mg + Atezolizumab
n=5 Participants
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab
n=43 Participants
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab
n=36 Participants
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab
n=9 Participants
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg + Atezolizumab
n=9 Participants
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=15 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
>= 18 - 64 years
|
2 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
27 Participants
n=43 Participants
|
27 Participants
n=36 Participants
|
5 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
8 Participants
n=15 Participants
|
5 Participants
n=14 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=14 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=9 Participants
|
133 Participants
n=222 Participants
|
|
Age, Customized
>= 65 to 84 years
|
2 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=43 Participants
|
9 Participants
n=36 Participants
|
4 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
7 Participants
n=15 Participants
|
9 Participants
n=14 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=14 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=9 Participants
|
88 Participants
n=222 Participants
|
|
Age, Customized
>= 85 years
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=222 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=43 Participants
|
20 Participants
n=36 Participants
|
5 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
6 Participants
n=15 Participants
|
6 Participants
n=14 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=14 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
6 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=9 Participants
|
118 Participants
n=222 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
23 Participants
n=43 Participants
|
16 Participants
n=36 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
9 Participants
n=15 Participants
|
8 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=9 Participants
|
104 Participants
n=222 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=43 Participants
|
6 Participants
n=36 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=9 Participants
|
28 Participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=43 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=9 Participants
|
8 Participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=222 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=43 Participants
|
28 Participants
n=36 Participants
|
6 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
14 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=14 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
8 Participants
n=9 Participants
|
181 Participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=43 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=43 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=222 Participants
|
|
Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Ethnicity was not collected from any participant.
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeksPopulation: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An serious AE (SAE) was any AE that: * resulted in death; * was life-threatening; * resulted in inpatient hospitalization or prolongation of existing hospitalization; * resulted in a persistent or significant disability/incapacity; * resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs; * constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=10 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=43 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=35 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Any TEAEs
|
—
|
4 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
43 Participants
|
34 Participants
|
9 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Any Serious TEAEs
|
—
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
17 Participants
|
11 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeksPopulation: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Dose changes were defined as infusion interruption and dose reduction.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=10 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=43 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=35 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants Experiencing Dose Changes
Dose Reduction
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants Experiencing Dose Changes
Infusion Interruption
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeksPopulation: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=10 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=43 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=35 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Absolute Dose Intensity
|
—
|
0.260 mg/week
Standard Deviation 0.0000
|
0.778 mg/week
Standard Deviation 0.0179
|
2.616 mg/week
Standard Deviation 0.0427
|
7.799 mg/week
Standard Deviation 0.2694
|
26.174 mg/week
Standard Deviation 0.1952
|
76.650 mg/week
Standard Deviation 4.8260
|
0.236 mg/week
Standard Deviation 0.0288
|
0.780 mg/week
Standard Deviation 0.0176
|
2.573 mg/week
Standard Deviation 0.1159
|
7.418 mg/week
Standard Deviation 1.1455
|
25.774 mg/week
Standard Deviation 0.9037
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeksPopulation: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=10 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=43 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=35 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Relative Dose Intensity
|
—
|
0.988 ratio
Standard Deviation 0.0189
|
0.978 ratio
Standard Deviation 0.0179
|
0.979 ratio
Standard Deviation 0.0179
|
1.015 ratio
Standard Deviation 0.0835
|
0.980 ratio
Standard Deviation 0.0058
|
0.958 ratio
Standard Deviation 0.0610
|
0.884 ratio
Standard Deviation 0.1071
|
0.978 ratio
Standard Deviation 0.0202
|
0.963 ratio
Standard Deviation 0.0432
|
0.928 ratio
Standard Deviation 0.1422
|
0.967 ratio
Standard Deviation 0.0316
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 21 daysPopulation: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
A DLT was defined as a clinically relevant AE or abnormal laboratory value of Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) ≥ Grade 3 assessed as unrelated to disease, PD, inter-current illness or concomitant medications, which occurs within the first cycle (21 days) of treatment with alomfilimab as single agent or in combination with atezolizumab during the dose escalation part of the study.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=10 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=43 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=35 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 162 weeksPopulation: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with measurable disease at baseline only for the purpose of evaluating ORR.
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% confidence interval (CI) was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=15 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
|
—
|
0 percentage of participants
Interval 0.0 to 21.8
|
0 percentage of participants
Interval 0.0 to 28.5
|
0 percentage of participants
Interval 0.0 to 45.9
|
7.1 percentage of participants
Interval 0.2 to 36.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 52.2
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0 percentage of participants
Interval 0.0 to 41.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectivelyPopulation: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received.
BOR for each participant was defined as the best confirmed response per RECIST 1.1 among all responses recorded from start of treatment until PD, initiation of new anti-cancer therapy, death, or analysis cut-off date, whichever comes first, with responses of: CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. Not evaluable (NE).
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=9 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=43 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=36 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=15 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR) Per RECIST 1.1
SD
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
12 Participants
|
8 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Best Overall Response (BOR) Per RECIST 1.1
PD
|
4 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
20 Participants
|
22 Participants
|
7 Participants
|
2 Participants
|
9 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Best Overall Response (BOR) Per RECIST 1.1
NE
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Best Overall Response (BOR) Per RECIST 1.1
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR) Per RECIST 1.1
PR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectivelyPopulation: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with observed events or participants that were censored for the purpose of evaluating PFS.
PFS was calculated as (first documented PD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=9 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=43 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=36 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=15 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) Per RECIST 1.1
|
3 months
Interval 2.0 to 4.0
|
2 months
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
2 months
Interval 1.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
2 months
Interval 1.0 to 6.0
|
3 months
Interval 1.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
2 months
Interval 1.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
1 months
Interval 1.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
3 months
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
2 months
Interval 2.0 to 4.0
|
2 months
Interval 2.0 to 2.0
|
2 months
Interval 1.0 to 4.0
|
4 months
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
2 months
Interval 1.0 to 4.0
|
2 months
Interval 2.0 to 2.0
|
2 months
Interval 1.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
2 months
Interval 1.0 to 4.0
|
4 months
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
2 months
Interval 1.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
2 months
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
3 months
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
2 months
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
4 months
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
2 months
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectivelyPopulation: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with observed events or participants that were censored for the purpose of evaluating duration of response.
Duration of response was calculated as (date of the first documentation of PD or to death due to any cause in the absence of PD - date of the first documentation of unconfirmed objective response \[CR or PR\] + 1\]/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants with no disease assessment (or only had assessments with response = NE) after first study treatment or have baseline or post-baseline assessments where the RECIST criteria could not be applied had their duration of response time censored. Duration of response was obtained via Kaplan Meier estimation.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=2 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=1 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=1 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=1 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response Per RECIST 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11 months
Confidence intervals could not be calculated as a single participant was analyzed.
|
6 months
Interval 2.1 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
NA months
Interval 13.9 to
Median and upper confidence intervals were not calculable due to fewer than 50% events.
|
11 months
Confidence intervals could not be calculated as a single participant was analyzed.
|
—
|
2 months
Confidence intervals could not be calculated as a single participant was analyzed.
|
—
|
—
|
13 months
Confidence intervals could not be calculated as a single participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
NA months
Median and confidence intervals could not be calculated as a single participant was censored.
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectivelyPopulation: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with measurable disease at baseline only for the purpose of evaluating ORR.
RECIST 1.1 has been modified to take into consideration the unique response kinetics which have been observed with immunotherapy in some patients where responses to immune therapies may occur after progression has been assessed. ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete immune-response (iCR) or partial immune-response (iPR) according to iRECIST as the best response. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). iCR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). iPR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=4 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=41 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=36 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=15 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ORR Per iRECIST
|
0 percentage of participants
Interval 0.0 to 41.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 33.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 60.2
|
9.3 percentage of participants
Interval 3.1 to 26.1
|
5.6 percentage of participants
Interval 0.8 to 21.4
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 23.2
|
0 percentage of participants
Interval 0.0 to 30.8
|
0 percentage of participants
Interval 0.0 to 45.9
|
7.1 percentage of participants
Interval 0.2 to 38.5
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 52.2
|
33.3 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectivelyPopulation: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with observed events or participants that were censored for the purpose of evaluating PFS.
PFS was calculated as (first documented iPD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method. iPD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=9 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=43 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=36 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=15 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PFS Per iRECIST
|
6 months
Interval 2.6 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
7 months
Confidence intervals could not be calculated as a single participant had observed events.
|
10 months
Interval 4.2 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
10 months
Interval 3.4 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
6 months
Interval 3.3 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
6 months
Interval 2.7 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
6 months
Interval 3.4 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
4 months
Interval 2.5 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
7 months
Interval 5.5 to 10.0
|
5 months
Interval 2.8 to 9.9
|
3 months
Interval 1.8 to 4.0
|
5 months
Interval 4.6 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
5 months
Interval 2.5 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
5 months
Interval 2.7 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
4 months
Interval 2.6 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
10 months
Interval 1.7 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
5 months
Interval 5.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
4 months
Interval 1.5 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
NA months
Median and confidence intervals could not be calculated as two participants were censored.
|
10 months
Confidence intervals could not be calculated as a single participant had observed events.
|
17 months
Confidence intervals could not be calculated as a single participant had observed events.
|
12 months
Confidence intervals could not be calculated as a single participant had observed events.
|
NA months
Median and confidence intervals could not be calculated as three participants were censored.
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 weeksPopulation: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. Inclusive of participants with measurable disease at baseline only.
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of CR or PR according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% CI was calculated using the exact binomial method (Clopper-Pearson). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=4 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=41 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=36 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: ORR Per RECIST 1.1
|
—
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 33.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 60.2
|
9.3 percentage of participants
Interval 3.1 to 26.1
|
5.6 percentage of participants
Interval 0.8 to 20.8
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
0 percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received.
Overall Survival rate was defined as the proportion of participants that had known survival status. Overall survival rate was obtained via Kaplan Meier estimation using the complimentary log-log transformation method.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=9 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=43 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=36 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=9 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=15 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival Rate at 12 and 24 Months
12 months
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 12 months.
|
0.2 proportion of participants
Interval 0.01 to 0.58
|
0.4 proportion of participants
Interval 0.1 to 0.73
|
0.3 proportion of participants
Interval 0.04 to 0.56
|
0.4 proportion of participants
Interval 0.1 to 0.73
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 12 months.
|
0.4 proportion of participants
Interval 0.05 to 0.75
|
0.4 proportion of participants
Interval 0.27 to 0.6
|
0.4 proportion of participants
Interval 0.22 to 0.57
|
0.2 proportion of participants
Interval 0.01 to 0.64
|
0.5 proportion of participants
Interval 0.12 to 0.82
|
0.2 proportion of participants
Interval 0.03 to 0.47
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 12 months.
|
0.6 proportion of participants
Interval 0.17 to 0.84
|
0.7 proportion of participants
Interval 0.38 to 0.88
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 12 months.
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
0.3 proportion of participants
Interval 0.01 to 0.77
|
|
Overall Survival Rate at 12 and 24 Months
24 months
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 24 months.
|
0.2 proportion of participants
Interval 0.01 to 0.58
|
0.3 proportion of participants
Interval 0.04 to 0.61
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 24 months.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 24 months.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 24 months.
|
0.3 proportion of participants
Interval 0.13 to 0.43
|
0.3 proportion of participants
Interval 0.11 to 0.44
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 24 months.
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 24 months.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 24 months.
|
0.2 proportion of participants
Interval 0.01 to 0.56
|
0.4 proportion of participants
Interval 0.13 to 0.66
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 24 months.
|
0.0 proportion of participants
Confidence intervals could not be calculated as no participants had known survival status at 24 months.
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
NA proportion of participants
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeksPopulation: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An SAE was any AE that: * resulted in death; * was life-threatening; * resulted in inpatient hospitalization or prolongation of existing hospitalization; * resulted in a persistent or significant disability/incapacity; * resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs; * constituted an important medical event. Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=15 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants Experiencing TEAEs
Any Serious TEAEs
|
—
|
6 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants Experiencing TEAEs
Any TEAEs
|
—
|
15 Participants
|
13 Participants
|
7 Participants
|
14 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeksPopulation: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Dose changes were defined as infusion interruption and dose reduction.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=15 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants Experiencing Dose Changes
Infusion Interruption
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants Experiencing Dose Changes
Dose Reduction
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeksPopulation: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=15 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Absolute Dose Intensity
|
—
|
0.778 mg/week
Standard Deviation 0.0540
|
2.559 mg/week
Standard Deviation 0.1712
|
0.777 mg/week
Standard Deviation 0.0111
|
2.536 mg/week
Standard Deviation 0.1628
|
2.366 mg/week
Standard Deviation 0.3577
|
6.818 mg/week
Standard Deviation 2.3926
|
0.775 mg/week
Standard Deviation 0.0212
|
2.640 mg/week
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
0.760 mg/week
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
2.607 mg/week
Standard Deviation 0.0841
|
2.613 mg/week
Standard Deviation 0.0551
|
7.794 mg/week
Standard Deviation 0.1676
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeksPopulation: Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=15 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Relative Dose Intensity
|
—
|
0.973 ratio
Standard Deviation 0.0660
|
0.956 ratio
Standard Deviation 0.0638
|
0.976 ratio
Standard Deviation 0.0113
|
1.014 ratio
Standard Deviation 0.1256
|
0.886 ratio
Standard Deviation 0.1316
|
0.980 ratio
Standard Deviation 0.0274
|
0.975 ratio
Standard Deviation 0.0212
|
0.990 ratio
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
0.960 ratio
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
0.977 ratio
Standard Deviation 0.0333
|
0.980 ratio
Standard Deviation 0.0200
|
0.973 ratio
Standard Deviation 0.0191
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)Population: PK Evaluable Set: consisted of all participants who had sufficient concentration-time data within the relevant phase to permit calculation of PK parameters for alomfilimab.
The serum pharmacokinetics (PK) of alomfilimab were characterized using non-compartmental analysis (NCA). Nominal times of sample collections were used for the NCA. All below limit of quantification (BLQ) values were set to 0 units.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=9 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=35 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=29 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=8 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Concentration (Cmax) of Alomfilimab
Cycle 1
|
—
|
0.3022 ug/mL
Standard Deviation 0.12476
|
0.9773 ug/mL
Standard Deviation 0.29919
|
3.3327 ug/mL
Standard Deviation 0.95752
|
8.7301 ug/mL
Standard Deviation 2.84671
|
33.7844 ug/mL
Standard Deviation 12.98646
|
124.4294 ug/mL
Standard Deviation 79.79754
|
0.3339 ug/mL
Standard Deviation 0.17905
|
1.1201 ug/mL
Standard Deviation 0.66885
|
3.3476 ug/mL
Standard Deviation 1.23416
|
8.2597 ug/mL
Standard Deviation 2.75396
|
31.4793 ug/mL
Standard Deviation 10.38008
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Maximum Concentration (Cmax) of Alomfilimab
Cycle 3
|
—
|
0.2671 ug/mL
Standard Deviation 0.06805
|
1.2029 ug/mL
Standard Deviation 0.24583
|
3.7461 ug/mL
Standard Deviation 0.86853
|
30.5647 ug/mL
Standard Deviation 39.72256
|
43.8045 ug/mL
Standard Deviation 14.07259
|
141.8131 ug/mL
Standard Deviation 62.54794
|
0.2840 ug/mL
Standard Deviation 0.24914
|
1.6449 ug/mL
Standard Deviation 3.01380
|
9.5099 ug/mL
Standard Deviation 28.23379
|
10.2883 ug/mL
Standard Deviation 3.86029
|
51.6622 ug/mL
Standard Deviation 41.65071
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)Population: PK Evaluable Set: consisted of all participants who had sufficient concentration-time data within the relevant phase to permit calculation of PK parameters for alomfilimab.
The serum PK of alomfilimab were characterized using NCA. Nominal times of sample collections were used for the NCA. All BLQ values were set to 0 units.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=9 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=4 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=36 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=30 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=8 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=9 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Half-life (t1/2) of Alomfilimab
Cycle 1
|
—
|
42.7633 hours
Standard Deviation 20.84762
|
72.2276 hours
Standard Deviation 9.56084
|
149.0872 hours
Standard Deviation 55.14152
|
226.2922 hours
Standard Deviation 75.20291
|
377.5444 hours
Standard Deviation 126.28273
|
356.4297 hours
Standard Deviation 109.96450
|
37.4777 hours
Standard Deviation 3.96733
|
93.0339 hours
Standard Deviation 33.82676
|
165.8783 hours
Standard Deviation 89.07566
|
174.9685 hours
Standard Deviation 79.39134
|
300.0089 hours
Standard Deviation 113.49910
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Half-life (t1/2) of Alomfilimab
Cycle 3
|
—
|
—
|
80.3268 hours
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
215.6472 hours
Standard Deviation 98.90118
|
358.6064 hours
Standard Deviation 143.16181
|
342.6067 hours
Standard Deviation 193.81667
|
273.6673 hours
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
116.0599 hours
Standard Deviation 42.16269
|
202.0099 hours
Standard Deviation 78.48781
|
230.5514 hours
Standard Deviation 103.13822
|
440.0235 hours
Standard Deviation 236.99886
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1: pre-infusion at all cycles (up to 69 cycles) + 90 days SFUP; Phase 2: pre-infusion at all cycles (up to 28 cycles) + 90 day SFUP (21 day cycle length)Population: Anti-drug Antibody Evaluable Set: consisted of all participants who received at least one dose of alomfilimab or atezolizumab and had ADA results available for analysis within the relevant phase.
Detection of ADA was assessed from blood samples taken during the study using validated bioanalytical methods. The number of participants who developed detectable anti-alomfilimab or anti-atezolizumab antibodies during any cycle or the safety follow-up period (SFUP) was calculated.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=7 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=4 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=3 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=7 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=5 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=36 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=34 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=8 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=6 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=13 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=11 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=6 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=12 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=3 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime
≥ 1 Positive Anti-alomfilimab Antibodies Result
|
—
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
9 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime
≥ 1 Positive Anti-atezolizumab Antibodies Result
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 8 (21 day cycle length)Population: Biomarker Evaluable Set: consisted of all participants who received at least one dose of study drug and had at least one of ICOS, FOXP3 and CD8 cells results available for analysis within the relevant phase.
Biological samples (e.g., archived and fresh tumor samples or blood samples) were collected for analysis of responsive biomarkers. The summary of change in the following markers were calculated: * FOXP3-ICOS double-positive cells per mm\^2 in the Tumor * CD8-positive cells per mm\^2 in the tumor * CD8-positive cells per mm\^2 in the invasive margin.
Outcome measures
| Measure |
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=2 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=3 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=3 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=3 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=3 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=16 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=16 Participants
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=3 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 Participants
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=5 Participants
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=4 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=8 Participants
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=1 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=2 Participants
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 Participants
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=2 Participants
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=1 Participants
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8
FOXP3-ICOS double-positive cells per mm^2 in the tumor
|
-397.437 cells per mm^2
Standard Deviation 307.3676
|
0.275 cells per mm^2
Standard Deviation 5.5649
|
21.905 cells per mm^2
Standard Deviation 30.1015
|
-50.323 cells per mm^2
Standard Deviation 42.9514
|
-42.210 cells per mm^2
Standard Deviation 26.6714
|
-29.318 cells per mm^2
Standard Deviation 28.0896
|
-67.160 cells per mm^2
Standard Deviation 59.7524
|
-18.860 cells per mm^2
Standard Deviation 33.2369
|
-129.334 cells per mm^2
Standard Deviation 118.3340
|
-90.589 cells per mm^2
Standard Deviation 115.9495
|
-117.610 cells per mm^2
Standard Deviation 174.4591
|
-3.653 cells per mm^2
Standard Deviation 6.5269
|
-58.865 cells per mm^2
Standard Deviation 65.7823
|
-45.618 cells per mm^2
Standard Deviation 34.5880
|
-51.293 cells per mm^2
Standard Deviation 56.8048
|
-76.331 cells per mm^2
Standard Deviation 63.0946
|
-437.660 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
-518.975 cells per mm^2
Standard Deviation 668.5624
|
—
|
-31.120 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
-149.445 cells per mm^2
Standard Deviation 137.0019
|
-197.940 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8
CD8-positive cells per mm^2 in the tumor
|
171.170 cells per mm^2
Standard Deviation 293.3937
|
-449.920 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
448.833 cells per mm^2
Standard Deviation 443.5399
|
47.126 cells per mm^2
Standard Deviation 294.7947
|
-105.110 cells per mm^2
Standard Deviation 190.2826
|
-11.532 cells per mm^2
Standard Deviation 169.8503
|
-371.857 cells per mm^2
Standard Deviation 884.7449
|
-218.017 cells per mm^2
Standard Deviation 282.9603
|
111.154 cells per mm^2
Standard Deviation 939.3540
|
174.339 cells per mm^2
Standard Deviation 693.8745
|
300.433 cells per mm^2
Standard Deviation 325.6656
|
21.925 cells per mm^2
Standard Deviation 56.3211
|
202.501 cells per mm^2
Standard Deviation 588.9525
|
-63.528 cells per mm^2
Standard Deviation 65.5904
|
318.470 cells per mm^2
Standard Deviation 385.7782
|
320.923 cells per mm^2
Standard Deviation 685.1093
|
-116.950 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
-1009.800 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
-34.840 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
181.120 cells per mm^2
Standard Deviation 147.3752
|
-39.600 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8
CD8-positive cells per mm^2 in the invasive margin
|
—
|
—
|
—
|
-229.600 cells per mm^2
Standard Deviation 114.8200
|
—
|
336.140 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
-422.680 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
—
|
-163.910 cells per mm^2
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Alomfilimab 0.8 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Alomfilimab 2.4 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Alomfilimab 8 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 5 deaths
Alomfilimab 24 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 7 deaths
Alomfilimab 80 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 5 deaths
Alomfilimab 240 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 4 deaths
Alomfilimab 0.8 mg + Atezolizumab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 5 deaths
Alomfilimab 2.4 mg + Atezolizumab
Serious events: 17 serious events
Other events: 39 other events
Deaths: 24 deaths
Alomfilimab 8 mg + Atezolizumab
Serious events: 11 serious events
Other events: 34 other events
Deaths: 22 deaths
Alomfilimab 24 mg + Atezolizumab
Serious events: 4 serious events
Other events: 9 other events
Deaths: 6 deaths
Alomfilimab 80 mg + Atezolizumab
Serious events: 3 serious events
Other events: 9 other events
Deaths: 3 deaths
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Serious events: 6 serious events
Other events: 15 other events
Deaths: 10 deaths
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Serious events: 2 serious events
Other events: 13 other events
Deaths: 10 deaths
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Serious events: 1 serious events
Other events: 7 other events
Deaths: 5 deaths
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Serious events: 2 serious events
Other events: 14 other events
Deaths: 7 deaths
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Serious events: 1 serious events
Other events: 5 other events
Deaths: 3 deaths
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Serious events: 4 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Alomfilimab 0.8 mg
n=4 participants at risk
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg
n=5 participants at risk
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg
n=10 participants at risk
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg
n=8 participants at risk
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg
n=7 participants at risk
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 240 mg
n=5 participants at risk
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 0.8 mg + Atezolizumab
n=5 participants at risk
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab
n=43 participants at risk
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab
n=35 participants at risk
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab
n=9 participants at risk
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg + Atezolizumab
n=9 participants at risk
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=15 participants at risk
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 participants at risk
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 participants at risk
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 participants at risk
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 participants at risk
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 participants at risk
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 participants at risk
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 participants at risk
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 participants at risk
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 participants at risk
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 participants at risk
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 participants at risk
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
2/10 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Chest pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Chills
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Death
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Face oedema
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Fatigue
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Medical device discomfort
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
2/6 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
Other adverse events
| Measure |
Alomfilimab 0.8 mg
n=4 participants at risk
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg
n=5 participants at risk
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg
n=10 participants at risk
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg
n=8 participants at risk
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg
n=7 participants at risk
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 240 mg
n=5 participants at risk
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 0.8 mg + Atezolizumab
n=5 participants at risk
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab
n=43 participants at risk
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab
n=35 participants at risk
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab
n=9 participants at risk
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 80 mg + Atezolizumab
n=9 participants at risk
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=15 participants at risk
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
n=14 participants at risk
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=7 participants at risk
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
n=14 participants at risk
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 participants at risk
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
n=5 participants at risk
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=2 participants at risk
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
n=1 participants at risk
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=1 participants at risk
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
n=6 participants at risk
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=3 participants at risk
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
n=8 participants at risk
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Stoma site inflammation
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
100.0%
1/1 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
3/15 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
21.4%
3/14 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.6%
5/43 • Number of events 6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
5/35 • Number of events 10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
21.4%
3/14 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
21.4%
3/14 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
2/10 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
37.5%
3/8 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.9%
9/43 • Number of events 15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
31.4%
11/35 • Number of events 20 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
3/9 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
3/9 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
5/15 • Number of events 8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
21.4%
3/14 • Number of events 6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
2/7 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
4/14 • Number of events 7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
5/35 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.6%
5/43 • Number of events 7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
8.6%
3/35 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Endocrine disorders
Immune-mediated hypothyroidism
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Eye disorders
Periorbital pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
37.5%
3/8 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
2/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.6%
5/43 • Number of events 9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
5/35 • Number of events 7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.4%
4/35 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
37.5%
3/8 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
2/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
8.6%
3/35 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.4%
4/35 • Number of events 6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
3/9 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Asthenia
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
2/7 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Chest pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Chills
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Fatigue
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
60.0%
3/5 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
18.6%
8/43 • Number of events 10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
10/35 • Number of events 11 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
42.9%
6/14 • Number of events 7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
21.4%
3/14 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
4/8 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Malaise
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.9%
9/43 • Number of events 15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
10/35 • Number of events 13 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
21.4%
3/14 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
General disorders
Swelling
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Eye infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Herpes zoster reactivation
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.6%
5/43 • Number of events 7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
60.0%
3/5 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.9%
9/43 • Number of events 14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.9%
8/35 • Number of events 8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
55.6%
5/9 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
66.7%
6/9 • Number of events 6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
26.7%
4/15 • Number of events 7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
4/14 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Blood pressure increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Body temperature decreased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Cardiac murmur
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Gamma-glutamyltransferase
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
3/15 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Lipase decreased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
9.3%
4/43 • Number of events 6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
21.4%
3/14 • Number of events 6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
7/35 • Number of events 9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
35.7%
5/14 • Number of events 5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
100.0%
1/1 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
2/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.4%
4/35 • Number of events 6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
2/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.6%
5/43 • Number of events 6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
2/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
28.6%
2/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour cavitation
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
37.5%
3/8 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
8.6%
3/35 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
100.0%
1/1 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
2/10 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.3%
7/43 • Number of events 10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
5/35 • Number of events 7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
3/6 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
2/10 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.9%
8/35 • Number of events 11 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
25.0%
2/8 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus haemorrhage
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
33.3%
1/3 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
22.2%
2/9 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
5.7%
2/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
9.3%
4/43 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.4%
4/35 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
6.7%
1/15 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
42.9%
3/7 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.0%
3/43 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.4%
4/35 • Number of events 4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
2/14 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
10.0%
1/10 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
40.0%
2/5 • Number of events 3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
14.3%
1/7 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
11.1%
1/9 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
20.0%
1/5 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
4.7%
2/43 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
13.3%
2/15 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
12.5%
1/8 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.9%
1/35 • Number of events 2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
7.1%
1/14 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
2.3%
1/43 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/2 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
16.7%
1/6 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
|
Vascular disorders
Superficial vein thrombosis
|
25.0%
1/4 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/10 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/43 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/35 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/9 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/15 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/7 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/14 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/5 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
50.0%
1/2 • Number of events 1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/1 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/6 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/3 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
0.00%
0/8 • AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER